GABA (Gamma Amino Butyric Acid) Medication for Tobacco

NCT00644137 | Completed Early Phase 1 DMC

• 4 other identifiers: 0701002184R01DA020752VA 0023DPMC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Keywords

smoking sensations; no cravings; desire to smoke

Outcome Measures

Primary Outcomes (1)

• We believe this medication will help people to stop smoking

  2 years

Study Arms (2)

A

EXPERIMENTAL

pregabalin 300mg/day given in conjunction with smoking cigarettes.

Drug: pregabalin; Other: cigarettes

2

EXPERIMENTAL

cigarettes given in conjunction with pregabalin

Drug: pregabalin; Other: cigarettes

Interventions

pregabalin DRUG

Help stop smoking

Also known as: 300mg/day for pregabalin with smoking cigarettes

2; A

cigarettes OTHER

help stop smoking with study medication

2; A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female and male smokers, aged 18 to 55 years
• History of smoking daily for the past 12 months
• at least 15 cigarettes daily
• In good health as verified by medical history
• screening examination
• screening laboratory tests
• not pregnant as determined by pregnancy screening, nor breast feeding
• using acceptable birth control methods.

You may not qualify if:

• History of pregabalin allergy
• Use of psychotropic medication antidepressants, antipsychotics DSM-IV axis I diagnosis (schizophrenia, bipolar disorder, major depression
• Dependence or abuse of alcohol or any other illicit or prescription drugs
• current use of any other tobacco products, including smokeless tobacco
• history of seizures
• Inability to fulfill all scheduled visits and examination procedures

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Pregabalin; Tobacco Products

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: August 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)