Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans (Vet Cat)
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|ClinicalTrials.gov Identifier: NCT05294263|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2022
Last Update Posted : October 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder Cannabis Use Disorder||Drug: Varenicline Drug: Placebo||Phase 2|
Screening and Eligibility Assessment. Individuals will be screened by the research study intake coordinator. An initial pre-screen focused on inclusion/exclusion psychiatric diagnoses, medical status, current medication regimen, and ability and willingness to commit to completion of study procedures will be used to initially determine potential study eligibility. Interested individuals will be given a full description of the study procedures and asked to read and sign an IRB-approved informed consent form before participating in a detailed, comprehensive screening and assessment phase.
Diagnostic/Descriptive Assessment. The MINI International Neuropsychiatric Interview (MINI) will be used to assess psychiatric and substance use diagnoses. A medical history and physical exam will be conducted to ensure that the individual is eligible to participate. In the event an individual is found to be ineligible to participate in this research protocol, he or she will be given an appropriate referral for further medical care or to an appropriate treatment program. If found eligible, a randomization visit will be scheduled, and ongoing cannabis and tobacco use will be tracked between initial assessment and randomization.
Treatment Assignment. 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. To achieve treatment balance, randomization will be stratified by gender and presence of comorbid psychiatric conditions (depression, PTSD, etc.) as both have been shown to modify cannabis use. The randomization allocation schedule will be developed by the study statistician (Partially blinded, A/B treatment) and all study staff, the investigative team and participants will remain blinded to study assignment until study completion or an otherwise medical necessity. The study randomization will be reviewed by the study statistician (partially blinded) on a regular basis to ensure that the schedule is being implemented according to plan. Final treatment assignment (A/B) and dispensing will be performed by the VA Investigational Pharmacy, a centralized research pharmacy that manages clinical trial medications. 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. Medication (varenicline and matching placebo capsules) will be compounded by Pitt Street Pharmacy, a local pharmacy that has been utilized previously by VA investigators. Dr. McRae-Clark holds an IND from the FDA for the use of varenicline in individuals with cannabis use disorder.
Medication Management. Medication Management (MM) is a common-sense, generalizable approach to encourage adherence to medication specifically, and to a treatment plan in general. Once a week, participants will be seen for a brief MM session. Sessions will be focused on (a) developing and maintaining rapport, (b) reviewing AEs and concomitant medications, and (c) discussing progress with medication adherence and cannabis reduction/abstinence. These sessions provide an opportunity to address challenges and help participants devise strategies for success.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Varenicline for Comorbid Tobacco and Cannabis Use in Veterans|
|Estimated Study Start Date :||January 2, 2023|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
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.
Varenicline is a selective nACHr partial agonist of the 4 2 subtype and a full agonist of the 7 subtype
Other Name: Chantix
Placebo Comparator: Placebo
Matching placebo will be administered over the 12-week period.
Matching, inactive medication
- Number of cannabis using day as reported on Timeline Followback [ Time Frame: Weeks 6-12 ]Number of cannabis using days as self-reported on TLFB
- Average number cigarettes smoked per day as reported on Timeline Followback [ Time Frame: Weeks 6-12 ]Average number of cigarettes smoked per day as self-reported on TFLB
- Number of participants engaged in study visits and treatment [ Time Frame: Week 12 ]Participants will be considered retained if they are actively engaged in study visits and treatment at Week 12
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): NCT05294263
|Contact: Aimee L Mcrae-Clark, PharmD||(843) 792-5216||Aimee.McRae-Clark@va.gov|
|Contact: Lisa Nunn||(843) firstname.lastname@example.org|
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|Contact: Sarah A Jackson, BA MA 843-789-6700 email@example.com|
|Principal Investigator: Aimee L. Mcrae-Clark, PharmD|
|Principal Investigator:||Aimee L. Mcrae-Clark, PharmD||Ralph H. Johnson VA Medical Center, Charleston, SC|