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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01314378
Other study ID # IBTP
Secondary ID 1R03DA0308992009
Status Active, not recruiting
Phase N/A
First received February 24, 2011
Last updated May 1, 2012
Start date January 2011
Est. completion date October 2012

Study information

Verified date May 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Dependence on tobacco derived nicotine is a major public health problem. Substance users who complete training in mindfulness subjectively report increased patience and improved motor control over their impulses. Yet, no studies have tested this perceived benefit with behavioral measures of impulse control. The investigators are conducting a randomized controlled clinical trial, which compares Cognitive-Behavioral Therapy and Mindfulness Training for tobacco smokers, using behavioral measures to investigate the effects of mindfulness training on impulsivity and inhibitory control.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Mindfulness Training
Eight session intensive behavioral training program for smokers
Cognitive-Behavioral Therapy
Eight session intensive behavioral intervention for smokers

Locations

Country Name City State
United States MGH Center for Addiction Medicine Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Massachusetts General Hospital Harvard University, Mind and Life Institute, Hadley, Massachusetts, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expired air carbon monoxide as measure of smoking status Primary Clinical Outcome Measure study week 16 No
Primary Behavioral impulsivity and response inhibition as measured with Experiential Discounting Task (EDT) and Stop-Signal Task (SST). Primary Outcome Measure for Impulsivity Study week 8 No
Secondary Biochemically verified 7-day point prevalence abstinence. Secondary Clinical Outcome Measure Study week 16 follow-up No
Secondary Minutes of mindfulness practice will correlate with performance change in both EDT and SST. Secondary Outcome Measure for Dose Effect Study week 8 No
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