Progesterone Augmentation of Nicotine Replacement Therapy Study

NCT02685072 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 1504015618R21CA198187
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Smoking Cessation; Nicotine Cessation

Outcome Measures

Primary Outcomes (1)

• 7-day Point Prevalence of Smoking Abstinence

  The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.

  end of 8 weeks of treatment

Secondary Outcomes (18)

• Carbon Monoxide <10 Ppm

  end of 8 weeks of treatment

• Carbon Monoxide <10 Ppm

  1 month follow up

• Carbon Monoxide <10 Ppm

  3 month follow up

• Change in Stroop Measure of Inhibitory Function

  baseline and week 2

• Change in Go/No Go Task Measure of Inhibitory Function

  baseline and week 2

Study Arms (2)

TNP + Progesterone

EXPERIMENTAL

Transdermal Nicotine Patch + Progesterone (200 mgs BID)

Drug: Progesterone (200 mgs BID)

TNP + Placebo

PLACEBO COMPARATOR

Transdermal Nicotine Patch + Placebo (for Progesterone)

Drug: Placebo

Interventions

Progesterone (200 mgs BID) DRUG

Transdermal Nicotine Patch (TNP) + Progesterone

Also known as: Prometrium

TNP + Progesterone

Placebo DRUG

TNP + Placebo

TNP + Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 - 45
• Smoking at least 5 cigarettes/ day for at least one year
• Regular menstrual cycles every 24-36 days for the previous 6 months
• Motivated to quit smoking (i.e., a rating of at least "7 "on a 10-point scale where 1 is not at all motivated and 10 is extremely motivated)
• In good health
• Using an acceptable, non-hormonal birth control

You may not qualify if:

• A history of major medical or psychological illnesses including:
• liver disease
• heart disease
• diabetes
• malignancy including history of breast cancer
• deep vein thrombosis
• blood coagulation problems including a history or family history of thrombophilia
• liver failure
• cervical intra-epithelial lesions III or greater that are untreated
• other medical conditions that the physician investigators deems will make study participation unsafe for the subject
• current or past history bipolar disorder or schizophrenia
• current diagnosis of major depression
• panic disorder or post-traumatic stress disorder
• active drug (non-nicotine) and/or alcohol dependence
• currently undergoing treatment with another pharmacological agent for smoking cessation

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale School of Medicine, Department of Psychiatry

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Kimberly Yonkers, MD
• Organization: Yale School of Public Health

kimberly.yonkers@yale.edu

(203) 764-6621

Study Officials

• Kimberly Yonkers, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: February 18, 2016
• Study Start: April 7, 2016
• Primary Completion: December 18, 2017
• Study Completion: March 12, 2018
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)