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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Gabapentin for Smoking Cessation

ClinicalTrials.gov ID: NCT00578552

Public ClinicalTrials.gov record NCT00578552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Gabapentin for Smoking Abstinence

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00578552
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Mayo Clinic
Other
Enrollment
80 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2007
Primary completion
Jan 31, 2009
Completion
Apr 30, 2009
Last update posted
Apr 18, 2011

2007 – 2009

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Mayo Clinic Nicotine Research Program Rochester Minnesota 55905

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00578552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 18, 2011 · Synced Sep 2, 2026

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Open the official record

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