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Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01484717
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
UConn Health

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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
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.




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: December 2, 2011    Key Record Dates
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