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| ID | Type | Description | Link |
|---|---|---|---|
| GCO# 21-0663 | Other Grant/Funding Number | National Institute On Drug Abuse/NIH/DHHS |
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The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.
In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone CBD | Active Comparator | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. |
|
| Methadone Placebo | Placebo Comparator | Matching placebo.in first dosing period and CBD 400mg in second dosing period |
|
| Buprenorphine CBD | Active Comparator | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. |
|
| Buprenorphine Placebo | Placebo Comparator | Matching placebo.in first dosing period and CBD 400mg in second dosing period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo twice daily for first 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale for Craving (VASC) | Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings. | Baseline and 4 weeks |
| Change in Visual Analog Scale Anxiety (VASA) | Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety. | Baseline and 4-weeks |
| Percentage of Participants With Positive Urine Toxicology | Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks. | 4-weeks |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) | Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden. | weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale for Craving (VASC) | Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving. |
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INCLUSION CRITERIA:
An individual who meets all of the following criteria will be eligible for study participation:
Individuals between 18 and 65 years old
Ability to understand and give informed consent.
Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview).
Current opioid agonist maintenance treatment in an opioid treatment program with methadone or buprenorphine for at least 14 days prior to study participation. With the following more specific criteria for each of these two medications:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation:
Participants who are non-English speaking.
Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe or which would prevent adherence to study procedure; examples include: suicidal or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder).
Current diagnosis of a severe substance use disorder (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
Alcohol intoxication when arriving at the study site (i.e., positive alcohol breathalyzer / alcohol salivary strips / urine alcohol).
Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.
Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
Showing signs of acute opioid withdrawal symptoms (as determined by the result of the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the investigator will be considered a positive result for withdrawal symptoms).
Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes, but is not limited to the following criteria:
Participating in another pharmacotherapeutic trial in the past 3 months.
Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study
For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm).
Participants who have been court mandated to attend treatment centers.
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| Name | Affiliation | Role |
|---|---|---|
| Yasmin Hurd, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
It is not yet known if there will be a plan to make IPD available, if the plan changes, the research team will share the plan details.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone CBD 200mg, Then CBD 400mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| FG001 | Methadone Placebo, Then CBD 400mg | Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| FG002 | Buprenorphine CBD 200mg, Then CBD 400mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| FG003 | Buprenorphine Placebo, Then CBD 400mg | Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Dosing Period: 4 Weeks |
|
| ||||||||||||||||||
| Second Dosing Period: 4 Weeks |
| |||||||||||||||||||
| No Medications Period: 4 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone CBD 200mg, Then CBD 400mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Visual Analog Scale for Craving (VASC) | Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings. | Results provide for participants who responded to the respective cues at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methadone CBD 200mg | Cannabidiol (CBD) 200mg for First 4 weeks twice daily adjunct with opioid agonist treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yasmin Hurd, PhD | Icahn School of Medicine at Mount Sinai | 212-824-9314 | yasmin.hurd@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2024 | Apr 1, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2024 | Dec 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Cannabidiol (CBD) 200mg | Drug | First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. |
|
| Cannabidiol (CBD) 400mg | Drug | Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
|
| 4-weeks and 8-weeks |
| Change in Visual Analog Scale Anxiety (VASA) | Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety. | 4-weeks and 8-weeks |
| Change in Percentage of Participants With Positive Urine Toxicology | Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks. | 4 weeks and 8 weeks |
| Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14) | Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving. | baseline and 4-weeks, 4-weeks and 8-weeks |
| Change in Generalized Anxiety Disorder Scale (GAD-7) | The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms. | Baseline and 4-weeks, 4-weeks and 8-weeks |
| Duration of Participant First Illicit Opioid Abstinence | any time during study, 8 weeks |
| Change in Patient Health Questionnaire (PHQ-9) | The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms. | baseline and 4-weeks, 4-weeks and 8-weeks |
| Positive and Negative Affect Schedule (PANAS-SF) | A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect. | baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue |
| Change in Heart Rate | Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied. | baseline and 8-weeks |
| Change in Blood Pressure | Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed. | baseline and 8-weeks |
| Change in Body Temperature | Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied. | baseline and 8-weeks |
| Change in Oxygen Level | Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline | baseline and 8-weeks |
| Change in Cue-induced Salivary Cortisol Levels | Study participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks. | Baseline and 4-weeks, 4-weeks and 8-weeks |
| Sleep Duration in Minutes Per Night | Average sleep duration measured across 8 weeks. | up to 8-weeks |
| Change in Insomnia Severity Index (ISI) | A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia. | baseline and 8-weeks |
| Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition | A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses. | baseline and 8-weeks |
| Change in The Symptom Check List 90 (SCL-90) | The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress. | baseline and 8-weeks |
| Change in Percentage of Participants With THC Positive in Urine. | Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine. | baseline and 4-weeks, 4-weeks and 8 weeks |
| Change in Plasma Level of THC Positive in Blood. | Change in plasma level THC Positive in - Substance use other than opioids measured in blood. | baseline and 4-weeks, 4-weeks and 8 weeks |
| Change in Concentration of Methadone Metabolites in Blood | Concentration of methadone metabolites measured in blood. | baseline and 4-weeks, 4-weeks and 8-weeks |
| Change in Concentration of Buprenorphine Metabolites in Blood | Concentration of buprenorphine metabolites measured in blood. | baseline and 4-weeks, 4-weeks and 8 weeks |
| Number of Participants Remaining in Treatment | Retention in treatment as measured by number of participants remaining in treatment. | up to 8 weeks |
| Change Methadone Dosage of Opioid Agonist Treatment | Change in the methadone dosage at Week 8 as compared to baseline. | baseline and 8 weeks |
| Number of CBD-COOH Positive Blood Toxicology | The number of CBD-COOH positive blood toxicology to measure adherence | 4 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 |
| Methadone Placebo, Then CBD 400mg |
Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| BG002 | Buprenorphine CBD 200mg, Then CBD 400mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| BG003 | Buprenorphine Placebo, Then CBD 400mg | Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Methadone Placebo, Then CBD 400mg | Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| OG002 | Buprenorphine CBD 200mg, Then CBD 400mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg: First 4 weeks: CBD (200mg)/Placebo twice daily adjunct with opioid agonist treatment. Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
| OG003 | Buprenorphine Placebo, Then CBD 400mg | Matching placebo.in first dosing period and CBD 400mg in second dosing period Placebo: Matching placebo twice daily for first 4 weeks Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. |
|
|
| Primary | Change in Visual Analog Scale Anxiety (VASA) | Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety. | Results provide for participants who responded to the respective cues at both timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4-weeks |
|
|
|
| Primary | Percentage of Participants With Positive Urine Toxicology | Percentage of participants with positive urine toxicology for illicit opioid use at 4 weeks. | Results provide for participants who provided urine sample at 4 weeks. | Posted | Number | Percentage of participants | 4-weeks |
|
|
|
| Primary | Systematic Assessment for Treatment Emergent Events (SAFTEE) | Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden. | Result provided for participants who completed the assessment for the respective week. | Posted | Mean | Standard Deviation | score on a scale | weekly for 8 weeks (Baseline, Week 1, 2, 3, 4, 5, 6, 7, and 8) |
|
|
|
| Secondary | Change in Visual Analog Scale for Craving (VASC) | Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving). Higher score indicates more extreme craving. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | score on a scale | 4-weeks and 8-weeks |
|
|
|
| Secondary | Change in Visual Analog Scale Anxiety (VASA) | Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety at 8 weeks as compared to 4 weeks (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Scale: 0 (not at all anxious) - 10 (extremely anxious). Higher score indicates more extreme anxiety. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | score on a scale | 4-weeks and 8-weeks |
|
|
|
| Secondary | Change in Percentage of Participants With Positive Urine Toxicology | Proportion of percentage with positive urine toxicology for illicit opioid use at 8 weeks as compared to 4 weeks. | Results provide for participants with data for both timepoints. | Posted | Number | Percentage of participants | 4 weeks and 8 weeks |
|
|
|
| Secondary | Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14) | Heroin Craving Questionnaire Short Form (HCQ-SF-14): A 15 minute, 14 item self-administered to measure general heroin craving. Each item is rated on a 7-point Likert scale (1= strongly disagree, 7= strongly agree). Full scale ranges from 14-98, with higher scores indicating more severe heroin craving. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline and 4-weeks, 4-weeks and 8-weeks |
|
|
|
| Secondary | Change in Generalized Anxiety Disorder Scale (GAD-7) | The General Anxiety Disorder 7-item questionnaire (GAD-7) assesses seven problem items potentially experienced over the past two weeks from "0" (not at all) to "3" (nearly every day). Individuals rank their levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more anxiety symptoms. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4-weeks, 4-weeks and 8-weeks |
|
|
|
| Secondary | Duration of Participant First Illicit Opioid Abstinence | Results only include participants who started with positive urine toxicology for illicit opioids at baseline. | Posted | Mean | Standard Deviation | weeks | any time during study, 8 weeks |
|
|
|
| Secondary | Change in Patient Health Questionnaire (PHQ-9) | The Questionnaire Type 9 for Depression (PHQ-9) measures depression severity with the nine DSM-IV criteria scored as "0" (not at all) to "3" (nearly every day). Full scale ranges from 0-27, with higher score indicating more severe symptoms. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline and 4-weeks, 4-weeks and 8-weeks |
|
|
|
| Secondary | Positive and Negative Affect Schedule (PANAS-SF) | A 20 item self-administered questionnaire evaluating current positive and negative affect. Each item is rated on a 5-point scale (0= Very slightly or not at all, 5= Extremely). Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline, 4-weeks and 8-weeks, post-cue collected within 10 minutes of pre-cue |
|
|
|
| Secondary | Change in Heart Rate | Heart rate (beats/min) will be monitored throughout the time course of the study and change at Week 8 from baseline will be studied. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | beats per min | baseline and 8-weeks |
|
|
|
| Secondary | Change in Blood Pressure | Blood pressure (in mmHg) will be monitored throughout the time course of the study and changes at week 8 as compared from baseline will be studied. Both diastolic and systolic pressures will be assessed. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | mmHg | baseline and 8-weeks |
|
|
|
| Secondary | Change in Body Temperature | Body temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes at week 8 from baseline will be studied. | Results provide for participants with both for specified timepoints. | Posted | Mean | Standard Deviation | degrees in Fahrenheit | baseline and 8-weeks |
|
|
|
| Secondary | Change in Oxygen Level | Oxygen level will be measured by pulse oximetry when vitals are collected. Change in oxygen level at week 8 as compared to baseline | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | percentage of SP02 | baseline and 8-weeks |
|
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|
| Secondary | Change in Cue-induced Salivary Cortisol Levels | Study participant will chew on a cotton swab providing a saliva sample from which free cortisol levels will be measured as an indicator of stress response in association with video cues. Thus, the stress of craving will be monitored and measured to observe any neutral cue induced changes from between baseline and 4 weeks, and between 4 weeks and 8 weeks. | Not Posted | Dec 2026 | Baseline and 4-weeks, 4-weeks and 8-weeks | Participants |
| Secondary | Sleep Duration in Minutes Per Night | Average sleep duration measured across 8 weeks. | Results provide for participants who provided data. | Posted | Mean | Standard Deviation | minutes per night | up to 8-weeks |
|
|
|
| Secondary | Change in Insomnia Severity Index (ISI) | A 5-10 minute, 7 question self-administered screening tool for insomnia. Each item rates the nature and symptoms of potential sleep problems using a 5-point Likert-type scale. Minimum score of 0 and maximum score of 28, with the highest score indicating prevalence and severity of insomnia. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8-weeks |
|
|
|
| Secondary | Change in The Digit Span Test Subtest of the Wechsler Adult Intelligence Scale 4th Edition | A 10-15 minute 30-item assessment that includes Digit Span Forward (DSF) and Digit Span Backward (DSB). DSF measures short-term memory, not working memory. DSB measures auditory working memory. Full scale from a minimum score of 0 and maximum score of 30, with the highest score indicating the total number of points achieved for correct responses. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8-weeks |
|
|
|
| Secondary | Change in The Symptom Check List 90 (SCL-90) | The Symptom Check List 90 (SCL-90): A 12-15 minute, 90 item self-administered psychometric instrument yielding nine scores of primary symptom dimensions (5-point rating scale; 1= Not at all, 5= Extremely), along with three scores based on global distress measures. Full scale ranges from a minimum score of 90 and maximum score of 450, with higher scores indicating more severe psychological distress. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline and 8-weeks |
|
|
|
| Secondary | Change in Percentage of Participants With THC Positive in Urine. | Change in percentage of participants with THC positive in Urine - Substance use other than opioids measured in urine. | Results provide for participants with data for specified timepoints. | Posted | Number | Percentage of participants | baseline and 4-weeks, 4-weeks and 8 weeks |
|
|
|
| Secondary | Change in Plasma Level of THC Positive in Blood. | Change in plasma level THC Positive in - Substance use other than opioids measured in blood. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | ng/ml | baseline and 4-weeks, 4-weeks and 8 weeks |
|
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| Secondary | Change in Concentration of Methadone Metabolites in Blood | Concentration of methadone metabolites measured in blood. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | ng/ml | baseline and 4-weeks, 4-weeks and 8-weeks |
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| Secondary | Change in Concentration of Buprenorphine Metabolites in Blood | Concentration of buprenorphine metabolites measured in blood. | Results provide for participants with data for specified timepoints. | Posted | Mean | Standard Deviation | ng/ml | baseline and 4-weeks, 4-weeks and 8 weeks |
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| Secondary | Number of Participants Remaining in Treatment | Retention in treatment as measured by number of participants remaining in treatment. | Posted | Count of Participants | Participants | up to 8 weeks |
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| Secondary | Change Methadone Dosage of Opioid Agonist Treatment | Change in the methadone dosage at Week 8 as compared to baseline. | Results provide for participants with data for both timepoints. | Posted | Mean | Standard Deviation | mg | baseline and 8 weeks |
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| Secondary | Number of CBD-COOH Positive Blood Toxicology | The number of CBD-COOH positive blood toxicology to measure adherence | Data for participants who provided blood specimen | Posted | Count of Participants | Participants | 4 weeks |
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| 0 |
| 32 |
| 0 |
| 32 |
| 12 |
| 32 |
| EG001 | Methadone Placebo | Matching placebo twice daily for first 4 weeks daily adjunct with opioid agonist treatment. | 0 | 30 | 0 | 30 | 21 | 30 |
| EG002 | Methadone CBD 400mg | Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. | 0 | 55 | 0 | 55 | 38 | 55 |
| EG003 | Buprenorphine CBD 200mg | CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks. Cannabidiol (CBD) 200mg for First 4 weeks twice daily adjunct with opioid agonist treatment. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | Buprenorphine Placebo | Matching placebo twice daily for first 4 weeks daily adjunct with opioid agonist treatment. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Buprenorphine CBD 400mg | Cannabidiol (CBD) 400mg: Second 4 weeks: All cohorts receive CBD (400mg) twice daily adjunct with opioid agonist treatment. | 0 | 13 | 0 | 13 | 6 | 13 |
| Diarrhea | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Fatigue | General disorders | SAFTEE | Systematic Assessment |
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| Headache | Nervous system disorders | SAFTEE | Systematic Assessment |
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| Increased appetite | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Insomnia | Nervous system disorders | SAFTEE | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | SAFTEE | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Dry Eyes | Eye disorders | SAFTEE | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Fever | General disorders | SAFTEE | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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| Nightmares | Nervous system disorders | SAFTEE | Systematic Assessment |
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| Loose Stool | Gastrointestinal disorders | SAFTEE | Systematic Assessment |
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Not provided
Not provided
Not provided
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| Change in VASA in response to drug cue |
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| Week 1 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| Change in VASC in response to drug cue |
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| Change in VASA in response to drug cue |
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| between week 4 and week 8 |
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| between week 4 and week 8 |
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| between week 4 and week 8 |
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| baseline positive post cue first session |
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| Baseline positive pre cue second session |
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| Baseline positive post cue second session |
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| Week 4 positive pre cue first session |
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| Week 4 positive post cue first session |
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| Week 4 positive pre cue second session |
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| Week 4 positive post cue second session |
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| Week 8 positive pre cue first session |
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| Week 8 positive post cue first session |
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| Week 8 positive pre cue second session |
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| Week 8 positive post cue second session |
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| Baseline negative pre cue first session |
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| Baseline negative post cue first session |
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| Baseline negative pre cue second session |
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| Baseline negative post cue second session |
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| Week 4 negative pre cue first session |
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| Week 4 negative post cue first session |
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| Week 4 negative pre cue second session |
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| Week 4 negative post cue second session |
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| Week 8 negative pre cue first session |
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| Week 8 negative post cue first session |
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| Week 8 negative pre cue second session |
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| Week 8 negative post cue second session |
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| diastolic |
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| week 4 and week 8 |
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| between week 4 and week 8 |
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| between week 4 and week 8 |
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| between week 4 and week 8 |
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