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

Sponsor

Jed E. Rose (Other)

Overall Status

Completed

CT.gov ID

NCT00900900

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Substance Withdrawal Syndrome	Dietary Supplement: dehydroepiandrosterone (DHEA) Dietary Supplement: pregnenolone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms. [6 months]

Secondary Outcome Measures

The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke. [6 months]
The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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