Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Cigarette Smoking Clinical Trial

Official title:

Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484717
• Other study ID #: 11-132-2
• Secondary ID: R21DA029215
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2011
• Last updated: February 16, 2017
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• contingency management for smoking abstinence
Participants earn the chance to win prizes for breath samples that test negative for cigarette smoking.

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.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longest duration of abstinence		Week 24