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Varenicline for Cannabis and Tobacco Use Disorders (Vet Cat Trial)
Phase 2
Recruiting
Led By Aimee L. Mcrae-Clark, PharmD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have body weight >110lbs (50kg) and have BMI between 18 and 35 kg/m2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 6-12
Awards & highlights
Vet Cat Trial Summary
This trial will study whether varenicline, a medication used to help people quit smoking, also helps people quit smoking cannabis.
Who is the study for?
This trial is for male and female Veterans who smoke at least five cigarettes daily, use cannabis three times a week, are interested in quitting or reducing their usage, and agree to birth control if applicable. Excluded are those pregnant, with severe renal issues or certain mental health conditions, on conflicting medications, or with recent serious cardiovascular events.Check my eligibility
What is being tested?
The study tests Varenicline (Chantix) against a placebo over 12 weeks to treat both cannabis and tobacco use disorders in Veterans. Participants will be randomly assigned to one of the treatments and have weekly check-ins involving tests and questionnaires.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep disturbances (like insomnia or vivid dreams), constipation, gas, vomiting. It can also lead to changes in taste or increased appetite which might affect weight.
Vet Cat Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh more than 110lbs and my BMI is between 18 and 35.
Vet Cat Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 6-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 6-12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average number cigarettes smoked per day as reported on Timeline Followback
Number of cannabis using day as reported on Timeline Followback
Other outcome measures
Number of participants engaged in study visits and treatment
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline
Vet Cat Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VareniclineExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be administered over the 12-week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,622 Previous Clinical Trials
3,323,583 Total Patients Enrolled
16 Trials studying Tobacco Use Disorder
2,935 Patients Enrolled for Tobacco Use Disorder
Aimee L. Mcrae-Clark, PharmDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during the trial.I am a Veteran aged 18 or older.I haven't had major heart problems like a heart attack in the last 6 months.You smoke at least five cigarettes per day.I agree to use birth control during the trial.You must want to stop or cut down on using cannabis and tobacco.I am not pregnant, nursing, or planning to become pregnant during the study.I weigh more than 110lbs and my BMI is between 18 and 35.I have not had a stroke or mini-stroke in the last 6 months.I am on stable doses of certain mental health medications, not including MAO-Is or benzodiazepines.I am currently taking medication that may interact with varenicline.I am a Veteran aged 18 or older.I am taking medication for mania or psychosis.I have severe kidney problems.I have a stable mood or anxiety disorder and have been on the same treatment for at least 2 months.You have used cannabis at least 3 days per week in the last 30 days.You must be willing to take the medication and be willing to commit to taking the medication.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Varenicline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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