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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
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
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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
    Placebo     Gabapentin - 1800 mg /Day     Gabapentin - 2700 mg/Day  
STARTED     27     27     26  
COMPLETED     12     13     11  
NOT COMPLETED     15     14     15  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Total Total of all reporting groups

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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