Behavioral Interventions to Target Self-Control

September 22, 2017 updated by: Laura Carim Todd, Oregon Health and Science University

Behavioral Interventions to Target Self-Control in Abstinent Nicotine Dependent Smokers

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Carim Todd, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1R21DA035877-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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