Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

NCT01484717 | Completed Phase 2 DMC

• 2 other identifiers: 11-132-2R21DA029215
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking remains the most common source of preventable morbidity and mortality in the United States, with in excess of $167 billion in economic costs per year. Contingency management (CM), in which tangible incentives are provided contingent on a target behavior like abstinence, is highly efficacious in improving substance abuse treatment outcomes and is receiving increased attention for smoking cessation. Expired carbon monoxide (CO) is the most common objective smoking status test used in smoking research and treatment. Unfortunately, multiple CO tests/day are typically required to detect all smoking and reinforce sustained abstinence. The resulting logistical and resource limitations greatly limit the application of this potentially powerful quit smoking toolset. This study addresses these limitations by examining the effectiveness of using interactive voice response technology (IVR) to implement CM. Smokers who want to quit (N = 90 randomized) will receive 2 quit preparation sessions based on public health guidelines for smoking cessation and set a target quit date. Participants will be randomly assigned to 1 of 2 treatment conditions: (a) IVR-S consisting of objective smoking status monitoring using IVR, telephone counseling and transdermal nicotine and (b) IVR-CM, consisting of the same monitoring, telephone counseling and transdermal nicotine plus IVR-based CM for smoking abstinence. It is hypothesized that abstinence rates will be higher in the IVR-CM condition compared to the IVR-S, supporting a combined IVR CM approach, and thereby greatly increasing the applicability of these powerful smoking cessation tools.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Longest duration of abstinence

  Week 24

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Telephone counseling plus nicotine patch

Drug: transdermal nicotine; Behavioral: Telephone counseling

Contingency management for abstinence from cigarettes

EXPERIMENTAL

Telephone counseling and nicotine patch plus contingency management

Behavioral: contingency management for smoking abstinence; Drug: transdermal nicotine; Behavioral: Telephone counseling

Interventions

contingency management for smoking abstinence BEHAVIORAL

Participants earn the chance to win prizes for breath samples that test negative for cigarette smoking.

Contingency management for abstinence from cigarettes

transdermal nicotine DRUG

Participants receive an 8 week supply of transdermal nicotine \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\].

Contingency management for abstinence from cigarettes; Standard Care

Telephone counseling BEHAVIORAL

Participants receive brief twice weekly telephone counseling.

Contingency management for abstinence from cigarettes; Standard Care

Eligibility Criteria

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

You may qualify if:

• regular cigarette smoker
• age ≥ 18
• mailing address \& valid photo I.D.
• want transdermal nicotine

You may not qualify if:

• not English speaking
• in recovery for pathological gambling
• contraindication for transdermal nicotine
• female who is pregnant, nursing a child, or not using effective contraception

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (1)

• Alessi SM, Rash CJ. Treatment Satisfaction in a Randomized Clinical Trial of mHealth Smoking Abstinence Reinforcement. J Subst Abuse Treat. 2017 Jan;72:103-110. doi: 10.1016/j.jsat.2016.06.013. Epub 2016 Jul 4.

  PMID: 27449226 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sheila Alessi, Ph.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

US (1)