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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA031906 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.
In the pilot study subjects will be treated with SATIVEX® (THC/cannabidiol combination in a buccal spray) using the same approach as outlined below for the randomized controlled trial. In the twelve-week, double-blind, placebo-controlled study visits will occur weekly during the medication phase of the study. The medication will be self-titrated over three weeks and a target quit date will be set up at Day 21. There will be a total of 12 weeks of drug exposure. Throughout these 12-weeks, all participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) in accordance with the intervention practices shown to be effective in treatment of cannabis dependence. The intervention will be adapted from the Brief Counselling for Marijuana Dependence manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA). At each study visit, vital signs and self-report ratings will be collected. In addition, the subjects will have to come daily to the centre to assess medication usage and will be asked to provide urine sample (two times weekly) and blood sample weekly. As there may be compliance issues, a contingency management approach will be also implemented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex | Experimental | Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy. |
|
| Placebo spray | Placebo Comparator | Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy |
|
| Pilot Study | Experimental | The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Enhancement/Cognitive Behavioral Therapy | Behavioral | All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Use (in Days) | The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report) | six months |
| Withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37692969 | Derived | Wang R, Trigo JM, Le Foll B. Effects of sub-chronic nabiximols on biological markers of individuals undergoing a clinical trial for the treatment of cannabis use disorder. Am J Transl Res. 2023 Aug 15;15(8):5228-5238. eCollection 2023. |
| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Study | The first five subjects will be treatment-seekers that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study. Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). |
| FG001 | Sativex | Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy. |
| FG002 | Placebo Spray | Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sativex | Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure associated with a weekly intervention of combined Motivational Enhancement/Cognitive Behavioral Therapy. Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tolerability | Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs. | Posted | Count of Participants | Participants | six months |
|
1 year, 10 months
ADVERSE EVENT COLLECTION BY QUESTIONNAIRE DURING STUDY VISITS (SAFTEE)
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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 | Sativex | Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). There will be a gradual increase of the maximal allowed dose starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays per day at the end of week 2. There will be a total of 12 weeks of drug exposure. All participants will receive a combination of pharmacotherapy (Sativex ) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose Trigo | CAMH | 416.535.8501 | 30021 | jose.trigo@camh.ca |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| C587251 | nabiximols |
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| D000431 | Ethanol |
| D003116 | Color |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002186 | Cannabinoids |
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| Sativex | Drug | Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure). |
|
|
| Placebo spray | Drug | Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure). |
|
|
Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.
Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal.
| six months |
| Cannabis Craving | Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana. | six months |
| Cannabis Use (Grams) | Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed | six months |
| BG001 | Placebo Spray | Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). |
| BG002 | Pilot Study | The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study. All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Pilot Study # of Participants That Withdrew Due SAE | The first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study. Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. Sativex: Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if |
|
|
| Secondary | Cannabis Use (in Days) | The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report) | Posted | Mean | Standard Deviation | percentage of days | six months |
|
|
|
| Secondary | Withdrawal | Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported. Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal. | Posted | Mean | Standard Deviation | Total Withdrawal score | six months |
|
|
|
| Secondary | Cannabis Craving | Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana. | Posted | Mean | Standard Deviation | Total Craving Scores | six months |
|
|
|
| Secondary | Cannabis Use (Grams) | Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed | Posted | Mean | Standard Error | grams of cannabis | six months |
|
|
|
| 0 |
| 20 |
| 16 |
| 20 |
| EG001 | Placebo Spray | Placebo spray: Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks Placebo treatment exposure. Participants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy | 0 | 20 | 18 | 20 |
| EG002 | Pilot Study | The first five subjects will be treatment-seekers that will be treated open-label. Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). There will be a total of 12 weeks medication treatment exposure). Motivational Enhancement/Cognitive Behavioral Therapy: All participants will receive a combination of pharmacotherapy (Sativex) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy. | 0 | 5 | 4 | 5 |
| Headache | Vascular disorders | Non-systematic Assessment |
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| Oro Mucal | Gastrointestinal disorders | Non-systematic Assessment |
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| Cold/Influenza | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Nightmare | General disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Mood Disturbance | Psychiatric disorders | Non-systematic Assessment |
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| Decrease in Libido | Psychiatric disorders | Non-systematic Assessment |
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| Decreased appetite | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Urinary Problems | Renal and urinary disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Skin rashes | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Indigestion | Gastrointestinal disorders | Systematic Assessment |
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| Light Headedness | Cardiac disorders | Systematic Assessment |
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| excessive sweating | Nervous system disorders | Systematic Assessment |
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| Ringing in ears | General disorders | Systematic Assessment |
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| Walking up in the middle of night | Psychiatric disorders | Systematic Assessment |
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| Tiredness | General disorders | Systematic Assessment |
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| D013729 |
| Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000438 | Alcohols |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D055585 | Physical Phenomena |