NCT03365362View on ClinicalTrials.gov

A Trial of Directly Observed and Long-term Varenicline

PHASE4CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

October 25, 2018

Primary Completion Date

November 14, 2023

Study Completion Date

April 24, 2024

Conditions
Tobacco Use DisorderOpioid-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

Trial Locations (1)

10467

Albert Einstein College of Medicine, The Bronx

Sponsors

Collaborators (1)

Pfizer
All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Pfizer

INDUSTRY

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Albert Einstein College of Medicine

OTHER

NCT03365362 - A Trial of Directly Observed and Long-term Varenicline | Biotech Hunter | Biotech Hunter