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

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

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.

Study Overview

• Status: Completed
• Conditions: Substance Withdrawal Syndrome
• Intervention / Treatment: Dietary supplement: dehydroepiandrosterone (DHEA); Dietary supplement: pregnenolone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Center for Nicotine & Smoking Cessation Research
    • Raleigh, North Carolina, United States, 27609
      • Duke Center for Nicotine & Smoking Cessation Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;
11. ulcers within the past 6 months;
12. lung disorder (including but not limited to COPD, emphysema, and asthma);
13. brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder);
14. history of fainting;
15. problems giving blood samples;
16. diabetes;
17. current cancer or treatment for cancer in the past 6 months (except basal or squamous cell skin cancer);
18. other major medical condition;
19. major depression, panic disorder, anxiety, bipolar disorder, schizophrenia, risk of suicide, or substance dependence other than nicotine dependence;
20. subjects who endorse suicidal ideation on the MINI abridged;
21. alcohol or drugs abuse;
22. reported use of illicit drugs within the past 30 days, or if the drug screen is positive;
23. reported use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, or nicotine replacement therapy; testosterone replacement therapy, DHEA or Pregnenolone; experimental (investigational) drugs; psychiatric medications (including antidepressants, anti-anxiety agents. anti-psychotics), sleep aids, medications that increase DHEA and/or DHEA-S concentrations (including, but not limited to: diltiazem, benfluorex, amlodipine, alprazolam, danazol, metformin, nitrendipine and retinol), or any other medications that are known to affect smoking (e.g. clonidine, muscle relaxants, opiate pain medications) within the past 2 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; one-time dose oral dose
Experimental: Dehydroepiandrosterone (DHEA)	Dietary supplement: dehydroepiandrosterone (DHEA); one-time 400mg oral dose of DHEA
Experimental: Pregnenolone	Dietary supplement: pregnenolone; one-time 400mg oral dose of pregnenolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jed E. Rose
• Investigators: Principal Investigator: Christine Marx, M.D., Duke University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): September 21, 2012
• Last Update Submitted That Met QC Criteria: September 14, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: DHEA; dehydroepiandrosterone; Cigarette Smokers; pregnenolone; Nicotine withdrawal symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: Pro00008225