The Effects of One-Time Pregnenolone, DHEA or Placebo Administration on Withdrawal Symptoms, Mood, Craving and Cigarette Evaluation Ratings in Male Smokers

The purpose of this study is to investigate DHEA, DHEAS, allopregnanolone, pregnenolone, other steroids, other small molecules, and proteins in the blood of male smokers to find out the possible relationship of these molecules to levels of nicotine dependence and negative emotions. 

We will recruit healthy males ages 18-65 from the Raleigh area for this study.

If you agree to participate in this study you will first come in for a screening visit. You will be given a physical examination to be sure you will not be put at any risk by being in this study. We will monitor your heart rate and blood pressure and collect a saliva sample. We will draw a sample of about 2 tablespoons (30ml) of blood from a vein in your arm, collect a urine sample and measure the carbon monoxide in your breath. You will also smoke one of your own brand of cigarettes through a smoking device, and fill out questionnaires. This visit will last approximately 2 1/2 hours. 

This study requires a total of 4 visits (1 screening and 3 laboratory visits). Each visit will be no less than 3 days apart and you will be asked to not smoke for 12 hours prior to each lab visit. At each lab visit we will take a saliva sample and monitor your heart rate, blood pressure and measure the carbon monoxidein your breath multiple times. You will have 2 blood samples taken from a vein in your arm using a needle (about 15 mL of blood each — a total of approximately 2 tablespoons per visit). 

At each lab visit, you will receive a one-time dose of either pregnenolone (400 mg orally), DHEA (400 mg orally) or placebo. You will smoke one cigarette through the same smoking device used at the screening. Twice during each visit, you will also be asked to perform an auditory arithmetic task called the PASAT. Throughout the day you will fill out various questionnaires. Each lab visit will last approximately 4 1/2 to 5 hours. 

There is ino cost to you to participate in this study. Any costs, including study procedures and supplies, will be paid for by the study. 

Subjects will be paid up to $410 for completing this study. Subjects will be compensated $100 for the laboratory sessions and an additional $50 for completing all the sesions. Subjects may also receive a $20 bonus at each session for their score on the PASAT, a paced mental arithmetic task. If you decide to withdraw from the study, you will be paid for the part of the study that you completed. Subjects will not be compensated for the physical screening visit.

For further information or to participate in this study, please call 888-525-DUKE or e-mail smoking@duke.edu

(IRB # 8225)