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A Trial of Directly Observed and Long-term Varenicline

NCT03365362 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2024-08-30

No results posted yet for this study

Summary

This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessation-achieving initial abstinence, preventing lapse and preventing relapse--necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes.

Conditions

  • Tobacco Use Disorder
  • Opioid-use Disorder

Interventions

DRUG

Long-Term Varenicline

Varenicline tablet x 24 weeks

DRUG

Short-Term Varenicline

varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg tablet

BEHAVIORAL

Directly Observed Therapy

Varenicline doses are administered by opioid treatment program nurses

BEHAVIORAL

Self Administered Therapy

Varenicline doses are self-administered

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Pfizer

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Shadi Nahvi, MD, MS · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2023-11-14
Completion
2024-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365362 on ClinicalTrials.gov