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Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484717
First Posted: December 2, 2011
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
UConn Health
  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
Intervention Model: Parallel Assignment
Masking: None (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 UConn Health:

Primary Outcome Measures:
  • Longest duration of abstinence [ Time Frame: Week 24 ]

Enrollment: 90
Study Start Date: January 2012
Study Completion Date: December 2014
Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484717


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sheila Alessi, Ph.D. UConn Health
  More Information

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT01484717     History of Changes
Other Study ID Numbers: 11-132-2
R21DA029215 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2011
First Posted: December 2, 2011
Last Update Posted: February 20, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action