← Back to Search

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 below
Select...
I weigh more than 110lbs and my BMI is between 18 and 35.

Vet Cat Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 6-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 6-12 for reporting.

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 • NCT04011280
50%
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
1,618 Previous Clinical Trials
3,316,035 Total Patients Enrolled
15 Trials studying Tobacco Use Disorder
2,840 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

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05294263 — Phase 2
Tobacco Use Disorder Research Study Groups: Placebo, Varenicline
Tobacco Use Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05294263 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05294263 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are additional participants sought for this investigation?

"This clinical trial, which was initially published on the 2nd of January 2023 and last amended on the 28th of October 2022, is no longer actively seeking participants. Nevertheless, 1,119 other studies are currently recruiting patients right now."

Answered by AI

Does the Food and Drug Administration recognize Varenicline as a viable treatment option?

"Our team at Power assigned Varenicline a safety score of 2 since there is some evidence backing up its safety, yet no data to demonstrate efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Ralph H. Johnson VA Medical Center, Charleston, SC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans
2023. "Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05294263.
All > Chantix
~82 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top