Mobile Contingency Management for Smoking Cessation in Returning US Veterans

NCT02513069 | Completed

• 1 other identifier: Pro00050835
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, and smoking cessation medications. The primary aim is to evaluate how effective this intervention is in promoting smoking abstinence compared to telehealth interventions for smoking cessation.

Conditions

Smoking; Veterans

Outcome Measures

Primary Outcomes (1)

• smoking, self-report

  Participants' self-report of smoking in the past seven days will be measured at 6-month follow-up study visit.

  6 month follow-up (6 months post-quit attempt)

Secondary Outcomes (5)

• saliva cotinine

  6 month follow-up (6 months post-quit attempt)

• smoking, self-report

  Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)

• saliva cotinine

  Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt)

• smoking, self-report

  3 month follow-up (3 months post-quit attempt)

• saliva cotinine

  3 month follow-up (3 months post-quit attempt)

Study Arms (2)

Mobile Contingency Management (mCM)

EXPERIMENTAL

The mCM arm represents a proactive tele-health intervention that combines guideline based cognitive-behavioral smoking cessation telephone counseling, a tele-medicine clinic for access to nicotine replacement therapy (NRT), and intensive behavioral therapy administered via a smart phone (with carbon monoxide monitor) based application. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date.

Other: Nicotine gum; Behavioral: mobile contingency management; Behavioral: Telephone counseling; Other: Nicotine patch; Other: Nicotine lozenge; Other: Smart phone; Other: Carbon monoxide monitor

Tele-Health for Smoking Ccessation

ACTIVE COMPARATOR

TELE-HEALTH FOR SMOKING CESSATION is a proactive tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same guideline based cognitive-behavioral smoking cessation telephone counseling, and tele-medicine clinic for access to NRT as in the mCM intervention. NRT may include nicotine patches (21 mg, 14 mg, and or 7 mg) used daily for six weeks from the smoking quit date. Dosage will depend on participants' reported smoking patterns and carbon monoxide readings. NRT may also include a "rescue" method, i.e., either nicotine gum or nicotine lozenge. The participants' preferred NRT rescue method will be prescribed and used as needed to reduce smoking craving for six weeks from the smoking quit date.

Other: Nicotine gum; Behavioral: Telephone counseling; Other: Nicotine patch; Other: Nicotine lozenge

Interventions

Nicotine gum OTHER

Participants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine gum as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings.

Also known as: nicotine polacrilex

Mobile Contingency Management (mCM); Tele-Health for Smoking Ccessation

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 reinforcement for videos that suggest smoking abstinence.

Also known as: mCM

Mobile Contingency Management (mCM)

Telephone counseling BEHAVIORAL

Participants receive five sessions of cognitive-behavioral telephone counseling, and a participant manual. The telephone counseling protocol included in this application is based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation and is informed by behavioral treatment principles .

Also known as: CBT for smoking cessation

Mobile Contingency Management (mCM); Tele-Health for Smoking Ccessation

Nicotine patch OTHER

Participants will be prescribed nicotine patches to be used during the post-quit phase of the study.

Also known as: Nicoderm

Mobile Contingency Management (mCM); Tele-Health for Smoking Ccessation

Nicotine lozenge OTHER

Participants will be prescribed one form of nicotine replacement "rescue" treatment (i.e., gum, lozenge), and may choose nicotine lozenge as the preferred "rescue" treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings.

Mobile Contingency Management (mCM); Tele-Health for Smoking Ccessation

Smart phone OTHER

Participants in the experimental condition will be loaned a smart phone to use during the mobile contingency management intervention period. The phone will be used to record videos of carbon monoxide readings to determine smoking abstinence.

Mobile Contingency Management (mCM)

Carbon monoxide monitor OTHER

Participants in the experimental condition will be loaned a CO monitor to use during the mobile contingency management intervention period. The monitor will be used to determine carbon monoxide content in the breath as a measurement of smoking.

Also known as: CO monitor

Mobile Contingency Management (mCM)

Eligibility Criteria

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

You may qualify if:

• Smoked at least 10 cigarettes on at least 15 of 30 days before screening
• Served during OEF/OIF/OND era
• Are willing to make a smoking cessation attempt
• Enrolled in the Durham VA for ongoing care
• English speaking

You may not qualify if:

• Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco
• Active diagnosis of a primary psychotic disorder per medical record
• Are currently imprisoned or in psychiatric hospitalization
• Severely impaired hearing or speech such that telephone counseling is not possible

Sponsors & Collaborators

• Duke University: lead
• Durham VA Medical Center: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Nicotine Chewing Gum; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Patrick S Calhoun, 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: July 28, 2015
• First Posted: July 31, 2015
• Study Start: January 1, 2015
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

US (1)