Cannabis Abuse
Conditions
Brief summary
Marijuana is the most commonly used illicit drug, and there is a high demand for effective treatments for cannabis use disorder, yet few specific pharmacological treatments have been developed. This study will evaluate the efficacy and safety of varenicline for reducing marijuana use in adults who use marijuana frequently. Participants will be randomized to receive either varenicline or placebo for 12 weeks, along with computerized cognitive behavioral therapy. Cannabis use, medication adherence, and safety outcomes will be assessed throughout treatment and at a follow-up visit.
Interventions
Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period.
DRUGPlacebo
Matched placebo administered daily for 12 weeks.
Sponsors
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
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
* Age ≥ 18 years * DSM-5 diagnosis of cannabis use disorder * Cannabis use ≥ 3 days per week in past 30 days * Ability to read English and provide informed consent * Willingness to comply with medication and study procedures * Agreement to use acceptable contraception if of childbearing potential
Exclusion criteria
* Pregnant, breastfeeding, or planning pregnancy * Severe renal impairment (CrCl \< 30 mL/min) * Lifetime bipolar I or II disorder, schizophrenia, or other psychotic disorder * Suicidal ideation or behavior within 6 months * Use of excluded psychotropic medications (e.g., bupropion, nortriptyline) * Moderate or severe non-cannabis substance use disorder (except nicotine) * Clinically significant cardiovascular or cerebrovascular disease in past 6 months * Hypersensitivity to varenicline * Participation in another investigational drug study within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannabis use reduction | Weeks 6-12 | The primary efficacy outcome is cannabis use reduction as measured by daily substance use logs and examined as the total number of use sessions at each weekly visit. |
| Group equivalence | Weeks 6-12 | There will equivalence of the average number of weekly use sessions reported between men and women. |
| Treatment responder classification | Weeks 6-12 | Determine what baseline demographic, cannabis use, and clinical characteristics best differentiate positive study treatment responders as compared to non-responders . |
Contacts
CONTACTLisa Program Manager, MS
Outcome results
None listed