A Trial of Directly Observed and Long-Term Varenicline
common.study.values.description
“A Trial of Directly Observed and Long-term Varenicline”
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 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs. The analytic strategy will evaluate the milestones in smoking cessationa?"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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
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common.study.values.methods
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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
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Achieving Smoking Cessation Milestones in Opioid Treatment Patients: a Randomized 2 x 2 Factorial Trial of Directly Observed and Long-term Varenicline
common.study.values.clinical-trial-id
NCT03365362
participant.views.study.view.id
penpDb
