Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

This study is currently recruiting participants.
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01484717
First received: November 30, 2011
Last updated: February 24, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Behavioral: contingency management for smoking abstinence
Drug: transdermal nicotine
Behavioral: Telephone counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Longest duration of abstinence [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484717

Contacts
Contact: Ellen Ciesielski 860-679-4556 eciesielski@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Principal Investigator: Sheila Alessi, Ph.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Sheila Alessi, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01484717     History of Changes
Other Study ID Numbers: 11-132-2, R21DA029215
Study First Received: November 30, 2011
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014