Cannabis Use Disorder
Conditions
Keywords
marijuana, substance use
Brief summary
Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.
Interventions
DRUGVarenicline
Active medication
DRUGPlacebo
Inactive medication
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days. * Express interest in receiving treatment for cannabis use disorder and reducing use. * Must be at least 18 years of age. * If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial. * Must consent to random assignment, and be willing to commit to medication ingestion. * Must be able to read and provide informed consent. * Must have body weight \>110lbs (50kg) and have BMI between 18 and 35kg/m2 * Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments.
Exclusion criteria
* Women who are pregnant, nursing, or plan to become pregnant during the course of the study. * Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute). * Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial). * Past year or current posttraumatic stress disorder. * Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year. * Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a risk assessment by a qualified medical professional is required. Subjects answering 'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified mental health professional. * Suicidal behavior within the past 10 years or a lifetime history of serious or recurrent suicidal behavior. * Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-MAO-I antidepressants, non-benzodiazepine anxiolytics, and ADHD medications. * Current use of medications prescribed for mania or psychosis. * Current use of buproprion or nortryptiline. * Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder. * Past year or current moderate or severe alcohol use disorder. * Individuals taking an investigational agent within the last 30 days before baseline visit. * Individuals with clinically significant medical disorders or lab abnormalities. * Any individual at screening with SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal and/or total bilirubin greater than two times the upper limit of normal. * Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, severe or unstable angina, serious arrhythmia, or any clinically significant ECG conduction abnormality. * Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke. * Hypersensitivity to varenicline. * Individuals who have participated in the clinical trial of any investigative compound within the last 60 days * Individuals who are on probation or under a mandate to obtain treatment. * Individuals with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Treatment phase Weeks 6-12 | Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | 12 weeks (across the active treatment period) | Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline 2 mg daily
Varenicline: Active medication | 90 |
| Placebo 2 mg daily
Placebo: Inactive medication | 84 |
| Total | 174 |
Baseline characteristics
| Characteristic | Varenicline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 84 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 12 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 72 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 28 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 57 Participants | 50 Participants | 107 Participants |
| Region of Enrollment United States | 90 participants | 84 participants | 174 participants |
| Sex: Female, Male Female | 33 Participants | 26 Participants | 59 Participants |
| Sex: Female, Male Male | 57 Participants | 58 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 84 |
| other Total, other adverse events | 81 / 90 | 70 / 84 |
| serious Total, serious adverse events | 1 / 90 | 0 / 84 |
Outcome results
Primary
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
Time frame: Treatment phase Weeks 6-12
Population: Week 6 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 7 | 9.4 number of weekly use sessions | Standard Deviation 8.2 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 9 | 8.5 number of weekly use sessions | Standard Deviation 7.6 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 6 | 10.3 number of weekly use sessions | Standard Deviation 8.2 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 11 | 8.4 number of weekly use sessions | Standard Deviation 7.5 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 8 | 9.4 number of weekly use sessions | Standard Deviation 7.9 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 12 | 8.4 number of weekly use sessions | Standard Deviation 8.6 |
| Varenicline | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 10 | 9.2 number of weekly use sessions | Standard Deviation 7.7 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 12 | 11.5 number of weekly use sessions | Standard Deviation 11.1 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 10 | 10.7 number of weekly use sessions | Standard Deviation 10.8 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 6 | 11.6 number of weekly use sessions | Standard Deviation 11.4 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 7 | 11.7 number of weekly use sessions | Standard Deviation 11.4 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 8 | 10.5 number of weekly use sessions | Standard Deviation 11.3 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 9 | 9.7 number of weekly use sessions | Standard Deviation 10.2 |
| Placebo | Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions | Week 11 | 11.8 number of weekly use sessions | Standard Deviation 12.8 |
Secondary
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.
Time frame: 12 weeks (across the active treatment period)
Population: Participants reporting an adverse event during 12 week active treatment period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | Serious adverse events related to treatment | 0 number of adverse events |
| Varenicline | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | Adverse events resulting in temporary or permanent medication discontinuation | 26 number of adverse events |
| Varenicline | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | Medication-related adverse events | 238 number of adverse events |
| Varenicline | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | All reported adverse events | 406 number of adverse events |
| Placebo | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | Medication-related adverse events | 115 number of adverse events |
| Placebo | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | All reported adverse events | 300 number of adverse events |
| Placebo | Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder | Adverse events resulting in temporary or permanent medication discontinuation | 14 number of adverse events |