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出境医 / 临床实验 / UH3 Varenicline for Cannabis Use Disorder

UH3 Varenicline for Cannabis Use Disorder

Study Description
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

Study Design
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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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
  • 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 with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA).
Contacts and Locations

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

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Wagner, MA, LPC    843-792-0484    wagne@musc.edu   
Behavioral Health Services of Pickens County Recruiting
Pickens, South Carolina, United States, 29671
Contact: Elizabeth Chapman, MA, LPC, LAC, AADC    864-898-2992    chapmanb@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Aimee McRae-Clark, PharmD Medical University of South Carolina
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE January 31, 2020
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UH3 Varenicline for Cannabis Use Disorder
Official Title  ICMJE Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE
  • Drug: Varenicline
    Active medication
    Other Name: Chantix
  • Drug: Placebo
    Inactive medication
    Other Name: Sugar pill
Study Arms  ICMJE
  • Experimental: Varenicline
    2 mg daily
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    2 mg daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019) 		174
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amanda Wagner, MA, LPC 843-792-0484 wagne@musc.edu
Contact: Lisa Nunn, MS 843-792-0476
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980561
Other Study ID Numbers  ICMJE PRO00089933
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aimee McRae-Clark, PharmD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date February 2021

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

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