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Trial record 41 of 147 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

August 30, 2016
September 8, 2016
February 1, 2018
February 13, 2017
December 13, 2018   (Final data collection date for primary outcome measure)
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").
  • 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) ]
    Change in BOLD fMRI signal
  • Cannabis use (as measured urine drug screening) [ Time Frame: 6 weeks ]
    Quantitative cannabinoid levels
  • Cannabis use (as measured by self-report) [ Time Frame: 6 weeks ]
    Time Line Follow Back data
Complete list of historical versions of study NCT02892110 on ClinicalTrials.gov Archive Site
  • Cannabis abstinence [ Time Frame: Weeks 3-6 of active treatment ]
    Quantitative cannabinoid levels (urine)
  • Cannabis craving (as measured by self-report) [ Time Frame: 6 weeks (across the active treatment period) ]
    Measured by Marijuana Craving Questionnaire
  • Cannabis use quantity reduction [ Time Frame: 6 weeks (baseline and end of treatment) ]
    Measured by Time Line Followback (self-report)
Not Provided
Not Provided
Not Provided
 
Varenicline Treatment for Cannabis Use Disorder
Advancing Varenicline as a Treatment for Cannabis Use Disorder
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Substance Use Disorder
  • Drug: Varenicline
    2 mg daily
    Other Name: Chantix
  • Drug: Placebo
    2 mg daily
  • Experimental: Varenicline
    2 mg daily
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    2 mg daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
June 13, 2019
December 13, 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Amanda Wagner, MA 843-792-0484 wagne@musc.edu
United States
 
 
NCT02892110
Pro00058198
UG3DA043231 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Aimee McRae-Clark, Medical University of South Carolina
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Principal Investigator: Aimee McRae-Clark, PharmD Medical University of South Carolina
Medical University of South Carolina
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP