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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA050325-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.
The rationale for the proposed research is to develop an acute intervention that can improve treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor contributing to early relapse. Although liraglutide was approved for human use in 2010, there are no data testing the effectiveness in patients with an OUD. The objective of the proposed research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information. If liraglutide shows a trend towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it would provide an indication to run the second phase, multi-center clinical trial of GLP-1R agonist in OUD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational group | Experimental | Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. |
|
| Control group | Placebo Comparator | Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide Pen Injector | Drug | Liraglutide will be provided using an injection pen provided by the manufacturer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS) | Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving. | Baseline (Day 1), End of the target drug dose (Day 19) |
| Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) | Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. | Baseline (Day 1), Treatment Days (Days 2-19) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period. | Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
| Change in Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs) | fNIRs indexes regional cerebral oxygenation saturation (%) by optical density (OD). Increased OD indicates increased blood oxygen saturation. | Baseline (Day 1), end of the target drug dose (Day 19) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Bunce, PhD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39061093 | Derived | Freet CS, Evans B, Brick TR, Deneke E, Wasserman EJ, Ballard SM, Stankoski DM, Kong L, Raja-Khan N, Nyland JE, Arnold AC, Krishnamurthy VB, Fernandez-Mendoza J, Cleveland HH, Scioli AD, Molchanow A, Messner AE, Ayaz H, Grigson PS, Bunce SC. Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder. Addict Sci Clin Pract. 2024 Jul 27;19(1):56. doi: 10.1186/s13722-024-00481-7. |
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Two participants were not randomized due to screening after consent and prior to randomization.
Protocol was approved for a 3-dose intervention that could continue as a 5-dose intervention; no participants received the latter. All outcomes are reported as the 3-dose intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Group | Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer |
| FG001 | Control Group | Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized participants in residential treatment for opioid use disorder
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Group | Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer |
| 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 Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS) | Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving. | In control group, n=1 did not complete the measure due to technical difficulties. n=7 instead of n=8 reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1), End of the target drug dose (Day 19) |
|
54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
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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 | Investigational Group | Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal syncope | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Bunce | Penn State College of Medicine | 215-510-8295 | sbunce@pennstatehealth.psu.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 21, 2023 | Sep 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2024 | Sep 6, 2024 | ICF_001.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 |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Placebo | Drug | Placebo injection pen |
|
Heart rate measurements in beats per minute.
| Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
| Change in Respiratory Rate | Respiratory rate in breaths per minute. | Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
| Absolute Change in Body Weight | Body weight will be measured in kilograms (kg). | From Day 1 to Day 19 |
| Percent Change in Body Weight | Body weight will be measured in kilograms (kg) and change will measured in %. | From Day 1 to Day 19 |
| Change in Fasting Blood Samples for Fructosamine | Fructosamine is measured in umol/L | From Day 2 to Day 19 |
| Change in Fasting Blood Samples for HA1c | HA1c is measured in % | From Day 2 to Day 19 |
| Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) | Number of participants affected by probable drug-related adverse events. | Days 1-21 and at 30 days post-intervention (Day 49). |
| Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) |
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. Treatment score is the average scores across Days 2-19. Rebound follow up score is the average scores across Days 20-21. |
| Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21) |
| Rebound Change in Blood Pressure | Blood pressure measurements in mmHg. Both pressures will be assessed during the study period. | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
| Rebound Change in Heart Rate | Heart rate measurements in beats per minute | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
| Rebound Change in Respiratory Rate | Respiratory rate in breaths per minutes. | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
| Screen fail after consent |
|
| Early withdraw criteria met |
|
| Non-compliance/difficulty with staff |
|
| BG001 | Control Group | Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen |
| BG002 | 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 |
| Control Group |
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen |
|
|
| Primary | Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) | Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. | n=1 did not complete entire EMA. n=7 instead of n=8 reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1), Treatment Days (Days 2-19) |
|
|
|
| Secondary | Change in Blood Pressure | Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
|
|
|
| Secondary | Change in Heart Rate | Heart rate measurements in beats per minute. | Posted | Mean | Standard Deviation | beats per minute | Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
|
|
|
| Secondary | Change in Respiratory Rate | Respiratory rate in breaths per minute. | Posted | Mean | Standard Deviation | breaths per minute | Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14) |
|
|
|
| Secondary | Absolute Change in Body Weight | Body weight will be measured in kilograms (kg). | Posted | Mean | Standard Deviation | kg | From Day 1 to Day 19 |
|
|
|
| Secondary | Percent Change in Body Weight | Body weight will be measured in kilograms (kg) and change will measured in %. | Posted | Mean | Standard Deviation | % change | From Day 1 to Day 19 |
|
|
|
| Secondary | Change in Fasting Blood Samples for Fructosamine | Fructosamine is measured in umol/L | In control group, n=1 could not obtain blood draw for measure. n=7 instead of n=8 reported. | Posted | Mean | Standard Deviation | umol/L | From Day 2 to Day 19 |
|
|
|
| Secondary | Change in Fasting Blood Samples for HA1c | HA1c is measured in % | Posted | Mean | Standard Deviation | % of total hemoglobin in the blood | From Day 2 to Day 19 |
|
|
|
| Secondary | Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) | Number of participants affected by probable drug-related adverse events. | Randomized participants | Posted | Count of Participants | Participants | Days 1-21 and at 30 days post-intervention (Day 49). |
|
|
|
| Other Pre-specified | Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs) | fNIRs indexes regional cerebral oxygenation saturation (%) by optical density (OD). Increased OD indicates increased blood oxygen saturation. | In placebo group, processing difficulties limited analysis. N=5 reported. | Posted | Mean | Standard Deviation | Optical density (OD) | Baseline (Day 1), end of the target drug dose (Day 19) |
|
|
|
| Other Pre-specified | Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) | Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. Treatment score is the average scores across Days 2-19. Rebound follow up score is the average scores across Days 20-21. | n=1 did not complete entire EMA. n=7 instead of n=8 reported. | Posted | Mean | Standard Deviation | score on a scale | Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21) |
|
|
|
| Other Pre-specified | Rebound Change in Blood Pressure | Blood pressure measurements in mmHg. Both pressures will be assessed during the study period. | Posted | Mean | Standard Deviation | mmHg | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
|
|
|
| Other Pre-specified | Rebound Change in Heart Rate | Heart rate measurements in beats per minute | Posted | Mean | Standard Deviation | beats per minute | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
|
|
|
| Other Pre-specified | Rebound Change in Respiratory Rate | Respiratory rate in breaths per minutes. | Posted | Mean | Standard Deviation | breaths per minute | From end of the target drug dose (Day 19) to rebound follow up (Day 21). |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 10 |
| 12 |
| EG001 | Control Group | Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen | 0 | 13 | 1 | 13 | 8 | 13 |
| Overdose to illicit drug | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| GI/abdominal upset | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hiccups | General disorders | Systematic Assessment |
|
| Continuing opioid withdrawal | General disorders | Systematic Assessment |
|
| Light headed | General disorders | Systematic Assessment |
|
| Ringing sensation | General disorders | Systematic Assessment |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Discomfort at Dexcom sensor site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shakiness, diaphoresis, and tremor | Metabolism and nutrition disorders | Systematic Assessment |
|
| Night terrors | Psychiatric disorders | Systematic Assessment |
|
| Intrusive thoughts or images | Psychiatric disorders | Systematic Assessment |
|
| Bleeding under Dexcom sensor | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin irritation spots | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Insect bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Systolic Pressure, from Day 14 |
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| Diastolic Pressure, from Day 2 |
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| Diastolic Pressure, from Day 8 |
|
| Diastolic Pressure, from Day 14 |
|
| Day 14 change from baseline |
|
| Day 14 change from baseline |
|