NCT02281942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

October 29, 2014

Last Update Submit

September 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time (minutes) to first smoke after 12-hour abstinence

    Assessed 1 week after visit 1 during a 2-hour abstinence reinforcement session

Study Arms (2)

Yoga

EXPERIMENTAL

Sequential movements in coordination to the breath cycle followed by seated and supine postures to release muscle tension.

Behavioral: Yoga

Education

PLACEBO COMPARATOR

A series of 30-minute recordings focused on different aspects of healthy living (e.g. diet, stress).

Behavioral: Education

Interventions

YogaBEHAVIORAL
Yoga
EducationBEHAVIORAL
Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Interventions

YogaEducational Status

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Laura Carim Todd, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 4, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations