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

Substance Withdrawal Syndrome Clinical Trial

— DHEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900900
• Other study ID #: Pro00008225
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2009
• Last updated: September 14, 2012
• Start date: July 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

Dietary Supplement:
• dehydroepiandrosterone (DHEA)
one-time 400mg oral dose of DHEA
• pregnenolone
one-time 400mg oral dose of pregnenolone

Drug:
• Placebo
one-time dose oral dose

Locations

Country	Name	City	State
United States	Duke Center for Nicotine & Smoking Cessation Research	Durham	North Carolina
United States	Duke Center for Nicotine & Smoking Cessation Research	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jed E. Rose

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.		6 months	No
Secondary	The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke.		6 months	No
Secondary	The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes.		6 months	No