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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jed E. Rose, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00900900
First received: May 11, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Substance Withdrawal Syndrome
Dietary Supplement: dehydroepiandrosterone (DHEA)
Dietary Supplement: pregnenolone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of One-Time Pregnenolone, DHEA, Or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
one-time dose oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900900

Locations
United States, North Carolina
Duke Center for Nicotine & Smoking Cessation Research
Durham, North Carolina, United States, 27705
Duke Center for Nicotine & Smoking Cessation Research
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Jed E. Rose
Investigators
Principal Investigator: Jed E Rose, Ph.D. Duke University
Principal Investigator: Christine Marx, M.D. Duke University
  More Information

No publications provided

Responsible Party: Jed E. Rose, Professor Department of Psychiatry and Behavorial Sciences, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00900900     History of Changes
Other Study ID Numbers: Pro00008225
Study First Received: May 11, 2009
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Cigarette Smokers
DHEA
dehydroepiandrosterone
pregnenolone
Nicotine withdrawal symptoms

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014