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

History of Changes

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
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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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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
Number of Participants [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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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Results Point of Contact:

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

No publications provided

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

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