Gabapentin for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00578552
First received: December 19, 2007
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

Gabapentin is an anti-epileptic agent that has shown preliminary evidence of efficacy for improving symptoms of cocaine and alcohol withdrawal in pilot studies. Since the neurobiology of alcohol, cocaine and nicotine withdrawal is similar, the preliminary evidence of efficacy of gabapentin for symptoms of alcohol and cocaine withdrawal suggests, that gabapentin might likely help nicotine withdrawal symptoms and thus tobacco abstinence. The effect of gabapentin on two of the neurotransmitters, gamma-aminobutyric acid (GABA) and glutamate further suggest a potential therapeutic mechanism for gabapentin in tobacco abstinence. However, the exact mechanism of action of gabapentin is currently not known. We have recently completed an open label pilot trial of gabapentin for tobacco abstinence involving 50 smokers. The findings from that study provide promising preliminary results and suggest that further testing of gabapentin for helping cigarette smokers quit tobacco use is worth pursuing. Overall, gabapentin is well tolerated and has low abuse potential.

Our goal is to evaluate novel, safe, acceptable, and effective therapies that may help increase tobacco abstinence rates. Currently, no randomized trials testing the efficacy of gabapentin for smoking abstinence have been published. While our previous study provides promising evidence regarding the potential efficacy of gabapentin for smoking abstinence, an additional dose ranging study is needed prior to pursuing a large randomized trial. The primary aim of the dose ranging study will be to obtain additional evidence of efficacy, and information on the optimal dose of gabapentin to employ in the larger randomized controlled trial.


Condition Intervention Phase
Cigarette Smoking
Tobacco Use
Drug: Placebo
Drug: Gabapentin - 1800 mg/day
Drug: Gabapentin - 2700 mg/day
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Gabapentin for Smoking Abstinence

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco [ Time Frame: 12 weeks following start of medication ] [ Designated as safety issue: No ]
    Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question "Have you used any type of tobacco, even a puff, in the past 7 days?" and (b) Expired Carbon Monoxide equal or less then 8 parts per million.


Enrollment: 80
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Non active placebo pill
Drug: Placebo
Placebo pill - non active sugar pill designed to look alike to the gabapentin medication
Other Name: placebo
Active Comparator: Gabapentin - 1800 mg/day
Gabapentin - 1800 mg/day
Drug: Gabapentin - 1800 mg/day
gabapentin - 1800 mg/day for 12 weeks.
Other Name: gabapentin
Active Comparator: Gabapentin - 2700 mg/day
Gabapentin - 2700 mg/day
Drug: Gabapentin - 2700 mg/day
gabapentin - 2700 mg/day for 12 weeks.
Other Name: gabapentin

Detailed Description:

A total of 120 participants will be recruited in this study and randomly assigned to one of the three groups. Participants in group A will receive gabapentin 1800-mg/day orally for 12-weeks while participants in group B will receive gabapentin 2700-mg/day orally for 12-weeks. Participants in group C will receive a matching placebo for the same duration. We have selected this dose regimen based on our experience with using gabapentin in the pilot study. The present study is designed as a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging, phase II clinical trial. In addition to receiving gabapentin or placebo, all subjects will receive a brief behavioral counseling intervention during participation in the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are between 18 to 65 years of age
  2. Have smoked ≥10 cigarettes/day for the past 1 year or more
  3. Are willing to make a quit attempt
  4. Are able to participate fully in all aspects of the study; and
  5. Have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

  1. Meet diagnostic criteria for current major depressive disorder or lifetime history of bipolar disorder or schizophrenia. Patients with mild or moderate depressive symptoms as assessed by the CES-D and determined by the physician, but who do not meet current diagnostic criteria for major depressive disorder, will be included
  2. Are currently (within past 30 days) using antipsychotics, or antidepressants
  3. Are currently (in previous 30 days) using any tobacco treatment program (i.e., behavioral therapy, nicotine replacement therapy, bupropion SR, clonidine, or nortriptyline)
  4. Have used an investigational drug within the 30 days prior to enrolling in this study
  5. Have recent history (in the past year) of alcohol abuse or dependence as assessed by the CAGE questionnaire and study investigators
  6. Have a recent history of drug abuse as assessed by the Drug Abuse Screening Test 20 (DAST-20) and physician interview
  7. Are pregnant, lactating, or of child bearing potential, likely to become pregnant during the medication phase and not willing to use contraception. The following birth control measures are acceptable: birth control pills, approved intra-uterine contraceptive devices, the use of two combined barrier methods (diaphragm with spermicide or condom with spermicide), injections, surgical sterilization and abstinence
  8. Have a history of any major cardio-vascular events in the past 6 months including unstable angina, acute MI or coronary angioplasty
  9. Have clinically significant acute or chronic progressive or unstable neurologic (myasthenia gravis), hepatic, renal, cardiovascular, respiratory (bronchospastic disease) or metabolic disease
  10. Are currently on the following prescribed medications known to interact with gabapentin and unable to stop them during the study: Maalox®, cimetidine and morphine. Patients will be cautioned not to use sedatives (such as benzodiazepines, antihistamines, anti-cholinergics, trazodone, zaleplon, anti-psychotics, barbiturates, opiates, zolpidem and eszopiclone) during the study
  11. Have another house-hold member or relative participating in the study
  12. Have known allergy to gabapentin or its constituents; and
  13. Are professional drivers or operators of heavy machinery and unable to refrain from these activities during the medication phase of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578552

Locations
United States, Minnesota
Mayo Clinic Nicotine Research Program
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amit Sood, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Amit Sood, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00578552     History of Changes
Other Study ID Numbers: 06-005262, 07-000700
Study First Received: December 19, 2007
Results First Received: November 1, 2010
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
tobacco
smoking
gabapentin
abstinence

Additional relevant MeSH terms:
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents

ClinicalTrials.gov processed this record on September 18, 2014