Status:
COMPLETED
The Effects of One-Time Pregnenolone, Dehydroepiandrosterone (DHEA), or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers
Lead Sponsor:
Jed E. Rose
Conditions:
Substance Withdrawal Syndrome
Eligibility:
MALE
18-65 years
Phase:
PHASE2
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 the...
Eligibility Criteria
Inclusion
- male;
- 18-65 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.
Exclusion
- 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;
- diabetes;
- current cancer or treatment for cancer in the past 6 months (except basal or squamous cell skin cancer);
- other major medical condition;
- major depression, panic disorder, anxiety, bipolar disorder, schizophrenia, risk of suicide, or substance dependence other than nicotine dependence;
- subjects who endorse suicidal ideation on the MINI abridged;
- alcohol or drugs abuse;
- reported use of illicit drugs within the past 30 days, or if the drug screen is positive;
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00900900
Start Date
July 1 2009
End Date
March 1 2011
Last Update
September 21 2012
Active Locations (2)
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1
Duke Center for Nicotine & Smoking Cessation Research
Durham, North Carolina, United States, 27705
2
Duke Center for Nicotine & Smoking Cessation Research
Raleigh, North Carolina, United States, 27609