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

Inclusion criteria

• 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 criteria

• 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.