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Progesterone Treatment in Female Smokers

NCT00000295Phase 2

Key facts

Status: Completed
Start: Apr 1999
Countries: 1
Sponsor: National Institute on Drug Abuse
Modality: Small Molecules

Drugs: progesterone
Conditions: Tobacco Use Disorder (TUD)

Overview

Phase 2, randomised, double-blind trial of progesterone in Tobacco Use Disorder (TUD) (2 arms), sponsored by National Institute on Drug Abuse. Primary endpoints: Behavioral Effects, Subjective Effects and 1 more. Started Apr 1999; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Progesterone -> Placebo
Participants receive Micronized Progesterone in session 1, then Placebo in session 2.
Placebo -> Progesterone
Participants receive Placebo in session 1, then Micronized Progesterone in session 2.

Who it enrols

Healthy female smokers aged 21-45, smoking >=20 cigarettes/day for >=1 year, not pregnant/breastfeeding, using non-hormonal birth control, without history of major medical/psychiatric conditions or other substance abuse.

Endpoints

Primary

Behavioral Effects2 hours post-treatment
Subjective Effectsduring experimental session
Biochemical Effectsduring experimental session

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