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Verified September 2016 by Medical University of South Carolina



National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Aimee McRae-Clark, Medical University of South Carolina

ClinicalTrials.gov Identifier:


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

Primary Outcome Measures:

  • 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Motivational enhancement therapy

Additional relevant MeSH terms:

Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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