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Behavioral Interventions to Target Self-Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281942
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Laura Carim Todd, Oregon Health and Science University

Brief Summary:
Low self-control has been associated with a number of unhealthy behaviors with low treatment success. Alternative non-pharmacological approaches have the potential for enhancing self-control. This pilot study will investigate if the practice of yoga and/or health and wellness education improve self-control in the context of nicotine addiction, and will set the stage for larger clinical trials using behavioral interventions to supplement or replace existing treatments and increase the rates of recovery from disorders in which low self-control is a susceptibility factor.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Yoga Behavioral: Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Interventions to Target Self-Control in Abstinent Nicotine Dependent Smokers
Study Start Date : May 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Yoga
Sequential movements in coordination to the breath cycle followed by seated and supine postures to release muscle tension.
Behavioral: Yoga
Placebo Comparator: Education
A series of 30-minute recordings focused on different aspects of healthy living (e.g. diet, stress).
Behavioral: Education



Primary Outcome Measures :
  1. Time (minutes) to first smoke after 12-hour abstinence [ Time Frame: Assessed 1 week after visit 1 during a 2-hour abstinence reinforcement session ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • should smoke a minimum of 10 cigarettes/day
  • be fluent speaking and reading English
  • in good physical health
  • intend to quit smoking
  • capable of abstaining from smoking for 12-14 hours
  • should have easy daily access to a computer and/or other internet-enabled device

Exclusion Criteria:

  • current alcohol or substance use disorder (except nicotine)
  • pregnancy
  • history of psychosis or bipolar disorder
  • current use of a behavioral or pharmacologic tobacco treatment
  • any untreated medical or psychiatric condition that might compromise their safety during participation in the study (e.g. high blood pressure, diabetes, BMI >35)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281942


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Laura Carim Todd, PhD Oregon Health and Science University
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Responsible Party: Laura Carim Todd, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02281942    
Other Study ID Numbers: 1R21DA035877-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017