Gabapentin for Smoking Cessation

This study has been completed.

Study NCT00578552 Information provided by Mayo Clinic

First Received on December 19, 2007. Last Updated on April 15, 2011 History of Changes

Results First Received: November 1, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment
Conditions:	Cigarette Smoking Tobacco Use
Interventions:	Drug: Placebo Drug: Gabapentin - 1800 mg/day Drug: Gabapentin - 2700 mg/day

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began on 08/07/2007 and completed on 12/10/2008. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Gabapentin - 1800 mg /Day	Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Gabapentin - 2700 mg/Day	Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Placebo	Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Gabapentin - 1800 mg /Day	Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Gabapentin - 2700 mg/Day	Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.

Baseline Measures

	Placebo	Gabapentin - 1800 mg /Day	Gabapentin - 2700 mg/Day	Total
Number of Participants [units: participants]	27	27	26	80
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	27	27	26	80
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	41.0 ± 11.1	41.1 ± 9.5	40.7 ± 13.5	40.9 ± 11.3
Gender [units: participants]
Female	11	11	8	30
Male	16	16	18	50
Cigarettes per day ^[1] [units: cigarettes per day] Mean ± Standard Deviation	20.0 ± 6.6	23.7 ± 6.9	20.9 ± 7.9	21.5 ± 7.2

[1]	Self Reported average number of cigarettes smoked per day in the preceeding 6 months prior to study enrollment.

Outcome Measures

1. Primary:

Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco [ Time Frame: 12 weeks following start of medication ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The original intent was to enroll a total of 120 subjects. However, due to the high study dropout rate, a review of the primary endpoint was performed after 80 subjects were enrolled and a decision was made to discontinue further enrollment.

Results Point of Contact:

Name/Title: Amit Sood
Organization: Mayo Clinic
phone: 507-266-1944
e-mail: nicotineresearch@mayo.edu

Publications of Results:

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