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Trial record 41 of 148 for:    cannabis | Recruiting, Enrolling by invitation Studies

Varenicline Treatment for Cannabis Use Disorder

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ClinicalTrials.gov Identifier: NCT02892110
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, 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
Substance Use Disorder Drug: Varenicline Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Advancing Varenicline as a Treatment for Cannabis Use Disorder
Actual Study Start Date : February 13, 2017
Estimated Primary Completion Date : December 13, 2018
Estimated Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Varenicline
2 mg daily
Drug: Varenicline
2 mg daily
Other Name: Chantix
Placebo Comparator: Placebo
2 mg daily
Drug: Placebo
2 mg daily



Primary Outcome Measures :
  1. Cannabis withdrawal during active treatment [ Time Frame: 6 weeks (across the active treatment period) ]
    Measured by the negative affect items of the Cannabis Withdrawal Scale (items 5 ["I felt nervous], 6 ["I had some angry outbursts"], 7 ["I had mood swings"], 8 ["I felt depressed"], 9 ["I was easily irritated"], 15 ["Life seemed an uphill struggle"], 18 ["I felt physically tense"], restlessness (item 11, "I felt restless), and/or urge to smoke (items 1 and 10, "The only thing I could think about was smoking some cannabis" and "I had been imagining being stoned").


Secondary Outcome Measures :
  1. Cannabis abstinence [ Time Frame: Weeks 3-6 of active treatment ]
    Quantitative cannabinoid levels (urine)

  2. Cannabis craving (as measured by self-report) [ Time Frame: 6 weeks (across the active treatment period) ]
    Measured by Marijuana Craving Questionnaire

  3. Cannabis use quantity reduction [ Time Frame: 6 weeks (baseline and end of treatment) ]
    Measured by Time Line Followback (self-report)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General 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 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.
  • 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 32kg/m2
  • Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments.

Additional Inclusion Criteria for fMRI Eligibility

  • Must be right-handed. General 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.

Additional Exclusion Criteria for fMRI Eligibility

  • Any psychiatric or medical issues, including claustrophobia, ferrous metal implants, pacemakers, or other electronic devices that would interfere with ability to participate in and successfully complete scanning procedures.
  • Any person unable to lie still within the fMRI scanner for the required period of time to obtaine useful images (use of anxiolytics will not be permitted for anxiety/claustrophobia related to scanning procedures).

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): NCT02892110


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

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
Marijuana use
Varenicline/Chantix
Motivational enhancement therapy

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs