Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation
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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 |
- 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 |
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| Contact: Ellen Ciesielski | 860-679-4556 | eciesielski@uchc.edu |
| United States, Connecticut | |
| University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: Sheila Alessi, Ph.D. | |
| 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: | January 15, 2013 |
| 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 May 23, 2013