Verified September 2016 by Medical University of South Carolina
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02892110
First received: August 30, 2016
Last updated: September 1, 2016
Last verified: September 2016
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.
| Substance Use Disorder | Drug: Varenicline Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Advancing Varenicline as a Treatment for Cannabis Use Disorder |
- Inhibitory control (as measured by neuroimaging-fMRI) [ Time Frame: 6 weeks (1 fMRI pre-varenicline and 1 f-MRI after six weeks of varenicline treatment) ] [ Designated as safety issue: No ]
Change in BOLD fMRI signal
- Cannabis use (as measured urine drug screening) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Quantitative cannabinoid levels
- Cannabis use (as measured by self-report) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Time Line Follow Back data
| Estimated Enrollment: | 72 |
| Study Start Date: | December 2016 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Experimental: Varenicline
2 mg daily |
Drug: Varenicline
2 mg daily Other Name: Chantix |
| Placebo Comparator: Placebo
2 mg daily |
Drug: Placebo
2 mg daily |
| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
- Must be between the ages of 18 and 65 years.
- If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial. Acceptable methods of birth control in this study are surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, a double-protection method (condom or diaphragm with spermicide), or abstinence.
- Must consent to random assignment, and be willing to commit to medication ingestion.
- Must be able to read and provide informed consent.
- Must function at an intellectual level sufficient to allow accurate completion of assessments.
- Desire to quit using cannabis.
Exclusion Criteria:
- Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
- Evidence of a significant medical condition which may affect capsule passage through the gastrointestinal tract (including, but not limited to, Crohn’s disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis).
- Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute).
- Lifetime history of DSM-5 mood or psychotic disorder.
- Suicidal ideation or behavior within the past 6 months.
- Concomitant use of psychotropic medications, other than stimulants or non-benzodiazepine sedative/hypnotics.
- Moderate or severe non-cannabis substance use disorders within the past 60 days.
- Current tobacco use.
- Hypersensitivity to varenicline, silver, magnesium, or any other capsule component.
- Individuals with embedded ferrous metal implants, pacemakers, or electronic devices.
- Individuals who are claustrophobic.
- Individuals with significant psychiatric or medical problems that would impair participation or limit ability to participate in scanning procedures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02892110
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
| Principal Investigator: | Aimee McRae-Clark, PharmD | Medical University of South Carolina |
| Responsible Party: | Aimee McRae-Clark, Professor of Psychiatry, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT02892110 History of Changes |
| Other Study ID Numbers: | Pro00058198 UG3DA043231 |
| Study First Received: | August 30, 2016 |
| Last Updated: | September 1, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medical University of South Carolina:
| Marijuana use Varenicline/Chantix Motivational enhancement therapy |
Additional relevant MeSH terms:
| Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Varenicline Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 07, 2016