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

NCT00900900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-09-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jed E. Rose

    lead OTHER

Principal Investigators

  • Jed E Rose, Ph.D. · Duke University

  • Christine Marx, M.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT00900900 on ClinicalTrials.gov