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Varenicline OTC Trial on Efficacy and Safety

NCT03557294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2024-09-19

Study results available
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Summary

The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.

Conditions

  • Tobacco Dependence
  • Withdrawal Symptoms
  • Smoking Cessation

Interventions

DRUG

1.0mg Varenicline b.i.d.

Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.

DRUG

0.5mg Varenicline b.i.d.

Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.

DRUG

0.0mg placebo Varenicline b.i.d.

Product that looks like active varenicline, but contains no active ingredient

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Los Angeles Clinical Trials

    collaborator UNKNOWN

  • University of Nevada, Reno

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Arizona State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2022-04-16
Completion
2022-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03557294 on ClinicalTrials.gov