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UH3 Varenicline for Cannabis Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03980561
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : February 7, 2020
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Varenicline Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Varenicline
2 mg daily
Drug: Varenicline
Active medication
Other Name: Chantix

Placebo Comparator: Placebo
2 mg daily
Drug: Placebo
Inactive medication
Other Name: Sugar pill

Primary Outcome Measures :
  1. Efficacy of varenicline, compared with placebo, for reducing cannabis use: total number of use sessions at each weekly visit [ Time Frame: Treatment phase Weeks 6-12 ]
    Cannabis use reduction as measured by daily substance use logs and examined as the total number of use sessions at each weekly visit.

Secondary Outcome Measures :
  1. Safety and tolerability of varenicline, compared with placebo, when used for cannabis use disorder: frequency of treatment-emergent AEs [ Time Frame: 12 weeks (across the active treatment period) ]
    Comparing the frequency of treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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).
  • Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal or homicidal risk (answers 'yes' on questions 4 or 5 of C-SSRS) will be referred for assessment by a qualified mental health professional.
  • 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.
  • 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 who are currently in any self-help program (e.g. AA, NA).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980561

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Contact: Amanda Wagner, MA 843-792-0484
Contact: Lisa Nunn, MS 843-792-0476

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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Wagner, MA    843-792-0484   
Contact: Patrick Cato    843-792-4215   
Behavioral Health Services of Pickens County Not yet recruiting
Pickens, South Carolina, United States, 29671
Contact: Elizabeth Chapman, BS, LCAC    864-898-5800   
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Aimee McRae-Clark, PharmD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina Identifier: NCT03980561    
Other Study ID Numbers: PRO00089933
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
substance use
Additional relevant MeSH terms:
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Marijuana Abuse
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