Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

NCT05294263 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: NURA-004-21SI01CX002357
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After initial eligibility screening, Veterans who use both cannabis and tobacco will be randomly assigned to receive either varenicline (Chantix) or placebo for 12 weeks. Participants will attend weekly visits, in person or remotely, to provide breath and urine samples for testing, fill out questionnaires, and meet with study staff about medication compliance.

Conditions

Tobacco Use Disorder; Cannabis Use Disorder

Keywords

Nicotine; Smoking; Tobacco Use Disorder; Cannabis; Marijuana Abuse; Marijuana Smoking; Cigarettes

Outcome Measures

Primary Outcomes (2)

• Number of cannabis using day as reported on Timeline Followback

  Number of cannabis using days as self-reported on TLFB

  Weeks 6-12

• Average number cigarettes smoked per day as reported on Timeline Followback

  Average number of cigarettes smoked per day as self-reported on TFLB

  Weeks 6-12

Other Outcomes (1)

• Number of participants engaged in study visits and treatment

  Week 12

Study Arms (2)

Varenicline

EXPERIMENTAL

Varenicline will be provided at the standard recommended dose of 0.5mg daily for three days, then 0.5mg twice daily for four days, and then 1mg twice daily for the remainder of the 12-week treatment period.

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Matching placebo will be administered over the 12-week period.

Drug: Placebo

Interventions

Varenicline DRUG

Varenicline is a selective nACHr partial agonist of the 4 2 subtype and a full agonist of the 7 subtype

Also known as: Chantix

Varenicline

Placebo DRUG

Matching, inactive medication

Placebo

Eligibility Criteria

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

You may qualify if:

• Meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
• Meet DSM-5 criteria for tobacco use disorder and smoke at least five cigarettes or report vaping 5 mg of nicotine daily.
• Males and female Veterans aged 18 and over.
• Be interested in quitting or reducing cannabis and tobacco use.
• 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 35 kg/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.
• Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, PTSD, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication/psychotherapy has been prescribed for at least 2 months prior to screening and no changes in current medication/psychotherapy expected during course of the trial).
• Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal (answers 'yes' on questions 4 or 5 of C-SSRS) or homicidal risk will be referred to assessment by a 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 (these medications may be allowed if used for other indications)
• Current use of bupropion, amitriptyline or nortryptiline or other medication known to have drug interactions with varenicline
• 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.
• Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, or severe or unstable angina).
• Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke
• Hypersensitivity to varenicline.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Marijuana Abuse; Marijuana Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Marijuana Use; Smoking, Non-Tobacco Products

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aimee L. Mcrae-Clark, PharmD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double Blind Placebo Controlled Trial: . Eligible individuals will be randomized to receive varenicline or matching placebo in a 1:1 manner utilizing a stratified random block design with block sizes of 2, 4 and 6.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 24, 2022
• Study Start: April 17, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)