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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00900900•Jed E. Rose

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. male;
•2. 18-65 years old;
•3. smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine;
•4. afternoon expired carbon monoxide reading of at least 10 ppm;
•5. in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.

Exclusion Criteria

•1. Participants must not have uncontrolled hypertension (systolic \>140 mm Hg, diastolic \>95 mm Hg)
•2. hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg);
•3. coronary heart disease;
•4. heart attack;
•5. cardiac rhythm disorder (irregular heart rhythm);
•6. chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source);
•7. cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
•8. liver or kidney disorder (except kidney stones, gallstones);
•9. gastrointestinal problems or disease other than gastroesophageal reflux,
•10. heartburn, or irritable bowel syndrome;
+13 more criteria

Locations (2)

Duke Center for Nicotine & Smoking Cessation Research

Durham, North Carolina, United States

Duke Center for Nicotine & Smoking Cessation Research

Raleigh, North Carolina, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

September 21, 2012

Enrollment

ACTUAL participants

Conditions

Substance Withdrawal Syndrome

Interventions

dehydroepiandrosterone (DHEA)

DIETARY_SUPPLEMENT

pregnenolone

DIETARY_SUPPLEMENT

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

Opioid Withdrawal Symptoms in Critically Ill Patients

Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

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