GABA (Gamma Amino Butyric Acid) Medication for Tobacco

08:38 EDT 1st November 2014 | BioPortfolio

Summary

The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.

Description

A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.

Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications.

Currently we have screened 26 subjects with 23 completers. This study is currently recruiting human subjects. Study is still active.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Nicotine Dependence

Intervention

pregabalin, cigarettes

Location

Yale University
New Haven
Connecticut
United States
06520

Status

Recruiting

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Strong dependence, both physiological and emotional, upon heroin.

Strong dependence, both physiological and emotional, upon morphine.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.

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