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Nicotinic Acetylcholine Receptor Partial Agonist
Long-Term Varenicline for Tobacco Use Disorder
Phase 4
Waitlist Available
Led By Shadi Nahvi, MD, MS
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Study Summary
This trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs.
Who is the study for?
This trial is for English or Spanish-speaking adults over 18 who are in opioid treatment, want to quit smoking, and smoke at least 5 cigarettes a day. They must be stable on methadone or buprenorphine and agree to use contraception. People with severe illnesses like AIDS, major heart disease, recent psychiatric hospitalization, alcohol use disorder, or those using varenicline recently can't join.Check my eligibility
What is being tested?
The study tests two approaches among smokers with opioid addiction: one where their medication (varenicline) is watched as they take it (directly observed therapy), and another where the medication is taken over a longer period. The goal is to see which helps more with quitting smoking—watching patients take their meds or letting them do it themselves for longer.See study design
What are the potential side effects?
Varenicline may cause nausea, sleep problems, constipation, gas; changes in taste; dry mouth; headaches; increased appetite; tiredness. It might also affect mood and behavior such as agitation or depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Initial abstinence
Time to lapse
Time to relapse
Secondary outcome measures
Cigarettes smoked per day
Durability of tobacco abstinence
Nicotine dependence
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Long-Term VareniclineExperimental Treatment1 Intervention
Participants will receive 24 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily)
Group II: Directly Observed TherapyExperimental Treatment1 Intervention
Participants receiving directly observed therapy (DOT) will receive varenicline from opioid treatment program nurses at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends.
Group III: Short-Term VareniclineActive Control1 Intervention
Participants will receive 12 weeks of varenicline at standard doses (0.5 mg/day for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily), followed by matching placebo twice daily through week 24.
Group IV: Self Administered TherapyActive Control1 Intervention
Patients receiving varenicline self administered therapy (SAT) will self-administer all varenicline doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Directly Observed Therapy
2019
N/A
~540
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,622,813 Total Patients Enrolled
272 Trials studying Tobacco Use Disorder
48,782 Patients Enrolled for Tobacco Use Disorder
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,856,962 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
245 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,203 Total Patients Enrolled
45 Trials studying Tobacco Use Disorder
25,885 Patients Enrolled for Tobacco Use Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used varenicline in the last 30 days.I have a history of seizures.I have been diagnosed with an alcohol use disorder.I currently smoke 5 or more cigarettes a day and have smoked at least 100 in my lifetime.I can participate in interviews in English or Spanish.My kidney function is low, with a creatinine clearance under 30 mL/min.I am currently diagnosed with major depression, bipolar disorder, or a psychotic disorder.I am not pregnant, breastfeeding, or planning to become pregnant.I have not had an AIDS-defining illness or been hospitalized for it in the past 6 months.I do not have severe liver disease with symptoms like poor blood clotting or low albumin.I haven't had serious heart issues like a heart attack or unstable angina in the last 6 months.I am 18 years old or older.I visit the clinic 1-6 times a week for methadone or buprenorphine.I have been in an opioid treatment program for at least 3 months.I agree to use birth control during the trial.My methadone or buprenorphine dose has been stable for two weeks.I have attempted suicide in the last year.I am currently having thoughts about harming myself.I want to quit smoking.I have severe asthma or COPD and needed oxygen or was hospitalized recently.
Research Study Groups:
This trial has the following groups:- Group 1: Directly Observed Therapy
- Group 2: Short-Term Varenicline
- Group 3: Self Administered Therapy
- Group 4: Long-Term Varenicline
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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