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

NCT00900900 | Completed Phase 2 DMC

• 1 other identifier: Pro00008225
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cigarette Smokers; DHEA; dehydroepiandrosterone; pregnenolone; Nicotine withdrawal symptoms

Outcome Measures

Primary Outcomes (1)

• The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.

  6 months

Secondary Outcomes (2)

• The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke.

  6 months

• The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes.

  6 months

Study Arms (3)

Dehydroepiandrosterone (DHEA)

EXPERIMENTAL

Dietary Supplement: dehydroepiandrosterone (DHEA)

Pregnenolone

EXPERIMENTAL

Dietary Supplement: pregnenolone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

dehydroepiandrosterone (DHEA) DIETARY_SUPPLEMENT

one-time 400mg oral dose of DHEA

Dehydroepiandrosterone (DHEA)

pregnenolone DIETARY_SUPPLEMENT

one-time 400mg oral dose of pregnenolone

Pregnenolone

Placebo DRUG

one-time dose oral dose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male;
• years old;
• 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;
• afternoon expired carbon monoxide reading of at least 10 ppm;
• in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.

You may not qualify if:

• Participants must not have uncontrolled hypertension (systolic \>140 mm Hg, diastolic \>95 mm Hg)
• hypotension (systolic \<90 mm Hg, diastolic \<60 mm Hg);
• coronary heart disease;
• heart attack;
• cardiac rhythm disorder (irregular heart rhythm);
• chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source);
• cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
• liver or kidney disorder (except kidney stones, gallstones);
• gastrointestinal problems or disease other than gastroesophageal reflux,
• heartburn, or irritable bowel syndrome;
• ulcers within the past 6 months;
• lung disorder (including but not limited to COPD, emphysema, and asthma);
• brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder);
• history of fainting;
• problems giving blood samples;

Sponsors & Collaborators

• Jed E. Rose: lead

Study Sites (2)

Duke Center for Nicotine & Smoking Cessation Research

Durham, North Carolina, 27705, United States

Location

Duke Center for Nicotine & Smoking Cessation Research

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Interventions

Dehydroepiandrosterone; Pregnenolone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenes; Pregnanes; Hydroxycorticosteroids; Progesterone Congeners

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Christine Marx, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Department of Psychiatry and Behavorial Sciences

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

US (2)