Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

NCT ID: NCT01484717

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

Telephone counseling plus nicotine patch

Group Type: ACTIVE_COMPARATOR

transdermal nicotine

Intervention Type: DRUG

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

Telephone counseling

Intervention Type: BEHAVIORAL

Participants receive brief twice weekly telephone counseling.

Contingency management for abstinence from cigarettes

Telephone counseling and nicotine patch plus contingency management

Group Type: EXPERIMENTAL

contingency management for smoking abstinence

Intervention Type: BEHAVIORAL

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

transdermal nicotine

Intervention Type: DRUG

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

Telephone counseling

Intervention Type: BEHAVIORAL

Participants receive brief twice weekly telephone counseling.

Interventions

contingency management for smoking abstinence

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

Intervention Type: BEHAVIORAL

transdermal nicotine

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

Intervention Type: DRUG

Telephone counseling

Participants receive brief twice weekly telephone counseling.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila Alessi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27449226 (View on PubMed)

Other Identifiers

R21DA029215

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-132-2

Identifier Type: -

Identifier Source: org_study_id