NCT00900900

The Effects of One-Time Pregnenolone, Dehydroepiandrosterone (DHEA), or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

The Effects of One-Time Pregnenolone, DHEA, Or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Jed E. Rose · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include assessing whether these agents relieve craving for cigarettes elicited by exposure to a mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and placebo will be administered one at each of the three sessions in a randomized order.

Conditions

• Substance Withdrawal Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dehydroepiandrosterone (DHEA)	one-time 400mg oral dose of DHEA
DIETARY_SUPPLEMENT	pregnenolone	one-time 400mg oral dose of pregnenolone
DRUG	Placebo	one-time dose oral dose

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-05-13
• Last updated: 2012-09-21

Locations

2 sites across 1 country: United States