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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
current cigarette smoking (smoked at least 100 cigarettes/lifetime, smoking ≥ 5 cigarettes/day)
English or Spanish speaking (i.e., be able to participate in study interviews in English or Spanish)
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I currently smoke 5 or more cigarettes a day and have smoked at least 100 in my lifetime.
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I can participate in interviews in English or Spanish.
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I am 18 years old or older.
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I visit the clinic 1-6 times a week for methadone or buprenorphine.
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I have been in an opioid treatment program for at least 3 months.
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I agree to use birth control during the trial.
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My methadone or buprenorphine dose has been stable for two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

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 more

Trial 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
2,447 Previous Clinical Trials
2,593,823 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
48,822 Patients Enrolled for Tobacco Use Disorder
Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,854,399 Total Patients Enrolled
3 Trials studying Tobacco Use Disorder
245 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,439 Total Patients Enrolled
45 Trials studying Tobacco Use Disorder
25,977 Patients Enrolled for Tobacco Use Disorder

Media Library

Long-Term Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03365362 — Phase 4
Tobacco Use Disorder Research Study Groups: Directly Observed Therapy, Short-Term Varenicline, Self Administered Therapy, Long-Term Varenicline
Tobacco Use Disorder Clinical Trial 2023: Long-Term Varenicline Highlights & Side Effects. Trial Name: NCT03365362 — Phase 4
Long-Term Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03365362 — Phase 4

Frequently Asked Questions

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

Does this trial require additional participants at the present time?

"Data hosted on clinicaltrials.gov verifies that this trial is presently recruiting participants, with the original post backdated to October 25th 2018 and the latest update being logged in May 19th 2022."

Answered by AI

How many individuals can participate in this investigation?

"Indeed, the clinicaltrials.gov website confirms that this investigation is still recruiting individuals as of May 19th 2022. It was first advertised on October 25th 2018 and requires 450 people from one trial site to take part in the study."

Answered by AI

What other investigations have looked into the efficacy of Directly Observed Therapy?

"Presently, there are 26 active clinical trials researching Directly Observed Therapy with 4 of them in Phase 3. Of these experiments, some originate from Charleston, South carolina while the remainder is located across 69 trial sites."

Answered by AI

Does the FDA sanction Directly Observed Therapy as an accepted procedure?

"Directly Observed Therapy was assigned a score of 3 due to the advanced stage of this study, as it has been approved by regulatory bodies."

Answered by AI

What is the main aim of this experiment?

"Over the course of 24 weeks, investigators will measure initial abstinence as their primary outcome and nicotine dependence (as quantified by Fagerstrom test), quality of life (assessed using Medical Outcomes Study Short Form 12)and durability of tobacco abstinence (CO-verified 7-day point prevalence at week 52)."

Answered by AI
~38 spots leftby Mar 2025