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S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence

This study has been completed.
Sponsor:
Collaborator:
Pharmavite
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00722124
First received: July 23, 2008
Last updated: August 5, 2011
Last verified: August 2011
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: S-Adenosyl-L-Methionine
Other: placebo

  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 10/07/08 and completed on 10/01/09. 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
SAMe 800 Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
SAMe 1600 Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
Placebo Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM

Participant Flow:   Overall Study
    SAMe 800   SAMe 1600   Placebo
STARTED   40   40   40 
COMPLETED   23   26   20 
NOT COMPLETED   17   14   20 



  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
SAMe 800 Each subject randomized to this arm will take a 400 mg pill of SAMe and one matching placebo pill in the AM and again in the PM
SAMe 1600 Each person randomized to this arm will take 2 400 mg pills of SAMe in the AM and again in the PM
Placebo Each subject randomized to this arm will take 2 placebo pills in the AM and again in the PM
Total Total of all reporting groups

Baseline Measures
   SAMe 800   SAMe 1600   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   40   120 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   34   40   38   112 
>=65 years   6   0   2   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.1  (16.0)   40.8  (12.3)   37.0  (13.6)   39.9  (14.1) 
Gender 
[Units: Participants]
       
Female   17   20   20   57 
Male   23   20   20   63 
baseline smoking rate [1] 
[Units: Cigarettes per day]
Mean (Standard Deviation)
 19.5  (9.3)   19.9  (8.4)   19.5  (8.0)   19.6  (8.5) 
[1] Average cigarettes per day at study entry


  Outcome Measures

1.  Primary:   7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)   [ Time Frame: 8 weeks ]


  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
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  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, MD
Organization: Mayo Clinic
phone: 507-266-1944
e-mail: nicotineresearch@mayo.edu



Responsible Party: Amit Sood, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00722124     History of Changes
Other Study ID Numbers: 07-006365
07-006604
Study First Received: July 23, 2008
Results First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board