Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Drug: transdermal nicotine; Behavioral: Telephone counseling; Behavioral: contingency management for smoking abstinence

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; Telephone counseling plus nicotine patch	Drug: transdermal nicotine; Participants receive an 8 week supply of transdermal nicotine [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)].; Behavioral: Telephone counseling; Participants receive brief twice weekly telephone counseling.
Experimental: Contingency management for abstinence from cigarettes; Telephone counseling and nicotine patch plus contingency management	Drug: transdermal nicotine; Participants receive an 8 week supply of transdermal nicotine [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)].; Behavioral: Telephone counseling; Participants receive brief twice weekly telephone counseling.; Behavioral: contingency management for smoking abstinence; Participants earn the chance to win prizes for breath samples that test negative for cigarette smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Longest duration of abstinence	Week 24

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sheila Alessi, Ph.D., UConn Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 11-132-2; R21DA029215 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No