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Progesterone Augmentation of Nicotine Replacement Therapy Study

NCT02685072 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-07-23

Study results available
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Summary

This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.

Conditions

  • Smoking Cessation

Interventions

DRUG

Progesterone (200 mgs BID)

Transdermal Nicotine Patch (TNP) + Progesterone

DRUG

Placebo

TNP + Placebo

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Kimberly Yonkers, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-07
Primary Completion
2017-12-18
Completion
2018-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02685072 on ClinicalTrials.gov