UH3 Varenicline for Cannabis Use Disorder

NCT03980561 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO00089933
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 2

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.

Conditions

Cannabis Use Disorder

Keywords

marijuana; substance use

Outcome Measures

Primary Outcomes (1)

• Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions

  Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.

  Treatment phase Weeks 6-12

Secondary Outcomes (1)

• Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder

  12 weeks (across the active treatment period)

Study Arms (2)

Varenicline

EXPERIMENTAL

2 mg daily

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

2 mg daily

Drug: Placebo

Interventions

Varenicline DRUG

Active medication

Also known as: Chantix, Apo-Varenicline

Varenicline

Placebo DRUG

Inactive medication

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Past year or current posttraumatic stress disorder.
• Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year.
• Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a risk assessment by a qualified medical professional is required. Subjects answering 'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified mental health professional.
• Suicidal behavior within the past 10 years or a lifetime history of serious or recurrent suicidal behavior.
• 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.
• Past year or current moderate or severe alcohol 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Substance-Related Disorders

Interventions

Varenicline; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates

Limitations and Caveats

Varenicline's efficacy for cannabis use disorder may vary by sex; however, this study was not powered to fully explore potential sex differences.

Results Point of Contact

• Title: Amanda Wagner
• Organization: MUSC

wagne@musc.edu

8437920484

Study Officials

• Aimee McRae-Clark, PharmD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: January 31, 2020
• Primary Completion: February 9, 2023
• Study Completion: December 1, 2023
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)