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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.
 
ClinicalTrials.gov Identifier: NCT03980561
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
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
Estimated Study Start Date : December 1, 2019
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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT03980561


Contacts
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Contact: Amanda Wagner, MA 843-792-0484 wagne@musc.edu
Contact: Lisa Nunn, MS 843-792-0476

Sponsors and Collaborators
Medical University of South Carolina
Investigators
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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
ClinicalTrials.gov Identifier: NCT03980561     History of Changes
Other Study ID Numbers: PRO00089933
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
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:
marijuana
substance use
Additional relevant MeSH terms:
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Marijuana Abuse
Disease
Pathologic Processes
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