Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD

NCT01990079 | Completed

• 1 other identifier: Pro00048990
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app.

Conditions

PTSD; Smoking

Keywords

PTSD; smoking

Outcome Measures

Primary Outcomes (1)

• smoking, self-report

  Participants' self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts.

  6 months follow-up

Secondary Outcomes (1)

• saliva cotinine

  6 months

Study Arms (2)

QUIT4Ever

EXPERIMENTAL

QUIT4EVER is an intervention that combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, mobile contingency management, and the smart-phone application Stay Quit Coach.

Drug: Bupropion; Drug: nicotine replacement therapy; Other: Smoking cessation counseling; Behavioral: mobile contingency management; Other: Stay Quit Coach

Control Contact Condition

ACTIVE COMPARATOR

This intervention combines 4 guideline-based smoking cessation counseling sessions, bupropion and nicotine replacement therapy, and mobile contingency management.

Drug: Bupropion; Drug: nicotine replacement therapy; Other: Smoking cessation counseling; Behavioral: mobile contingency management

Interventions

Bupropion DRUG

All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up.

Also known as: Zyban, Wellbutrin

Control Contact Condition; QUIT4Ever

nicotine replacement therapy DRUG

Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings

Also known as: nicotine gum, patch, inhaler, or lozenge

Control Contact Condition; QUIT4Ever

Smoking cessation counseling OTHER

Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.

Control Contact Condition; QUIT4Ever

mobile contingency management BEHAVIORAL

Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.

Also known as: mCM

Control Contact Condition; QUIT4Ever

Stay Quit Coach OTHER

Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.

Also known as: smart phone app

QUIT4Ever

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for current PTSD;
• Has current smoking status of at least 10 cigarettes per day (verified with breath carbon monoxide measurement);
• Has been smoking for at least 1 year;
• Is aged 18 to 70;
• Can speak and write current fluent conversation English; and
• Is willing to make a smoking cessation attempt.

You may not qualify if:

• Is pregnant;
• Has diagnosis, based on DSM-IV criteria, of schizophrenia, schizophreniform disorder, schizoaffective disorder, current psychotic symptoms, delusional disorder, current (not in remission) substance use disorder, and/or current manic episode;
• Will not be stable on medications for the study period;
• Has history of myocardial infarction in past 6 months;
• Uses any other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use during study period; or
• Is currently imprisoned.
• Note: Participants may be excluded or asked to refrain from taking certain study medications if they have a seizure disorder, uncontrolled diabetes, an eating disorder, or current or past cirrhosis or hepatitis.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

Related Publications (1)

• Hicks TA Bs, Thomas SP, Wilson SM, Calhoun PS, Kuhn ER, Beckham JC. A Preliminary Investigation of a Relapse Prevention Mobile Application to Maintain Smoking Abstinence Among Individuals With Posttraumatic Stress Disorder. J Dual Diagn. 2017 Jan-Mar;13(1):15-20. doi: 10.1080/15504263.2016.1267828. Epub 2016 Dec 5.

  PMID: 27918881 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Smoking

Interventions

Bupropion; Nicotine Replacement Therapy; Nicotine Chewing Gum; Transdermal Patch; Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Equipment and Supplies

Study Officials

• Jean C. Beckham, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (1)