- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281942
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
Intervention / Treatment
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.
Clinical Trials on Tobacco Smoking
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Johns Hopkins UniversityNational Center for Advancing Translational Sciences (NCATS); Community Partnership...CompletedSmoking Cessation | Smoking Reduction | Smoking, TobaccoUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
University of Colorado, DenverUniversity of OklahomaRecruitingSmoking Cessation | Tobacco | Quitting Smoking | Tobacco Abstinence | Smoking (Tobacco) Addiction | Smoking ( Cigarette)United States
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI)CompletedTobacco Smoking | Cigarette Smoking | Smoking, TobaccoUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Completed
-
RAI Services CompanyRecruitingSmoking | TobaccoUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States
Clinical Trials on Education
-
Erzincan UniversityCompletedQuality of Life | Nursing Caries | Breastfeeding | Postpartum | Nursing Model | Levine Conservation Model
-
Oregon Health and Science UniversityEnrolling by invitation
-
Mexican National Institute of Public HealthUniversity of North Carolina, Chapel Hill; Danone ResearchCompleted
-
Mclean HospitalCompleted
-
University of South FloridaNational Cancer Institute (NCI)WithdrawnPediatric CancerUnited States
-
Jen-Ai Hospital Institutional Review BoardEnrolling by invitation
-
University of TartuRecruiting
-
Simon Fraser UniversityNatural Sciences and Engineering Research Council, CanadaNot yet recruiting
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruiting
-
Marmara UniversityCompleted