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Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

Primary Purpose

Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
contingency management for abstinence
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age >21 years
  • frequent alcohol use
  • willing to use a cell phone and breathalyzer for 28 days
  • have a valid photo ID (driver's license, passport, state ID)
  • are willing to sign an off-campus property transfer form and return study equipment in four weeks

Exclusion Criteria:

  • desire for, or have received, treatment for alcohol use in the past 6 months
  • non-English speaking

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Monitoring Alone

Monitoring plus contingency management for abstinence

Arm Description

Research assistants will phone or text participants and request videorecordings of breathalyzer samples up to 21 times per week. Participants will receive compensation for each valid videorecording that occurs within the requested one-hour time frame, and bonus compensation each time all requested videorecordings are submitted within the timeframe over a 7-day period, and/or if >90% of prompts are returned over the study period.

Participants assigned to this condition will receive the same monitoring schedule outlined above, plus the same payment for compliance. In addition, they will receive contingent reinforcement for submission of videorecordings that demonstrate negative breath alcohol samples. For each sample submitted that reads below the cut point, participants will receive vouchers for payment.

Outcomes

Primary Outcome Measures

proportion of negative breath samples submitted

Secondary Outcome Measures

Full Information

First Posted
February 28, 2011
Last Updated
July 18, 2018
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01307345
Brief Title
Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence
Official Title
Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot project proposes to monitor real-world alcohol use using a novel technology-cell phone videorecordings in conjunction with breathalyzer recordings-and to conduct a small randomized study of this technology for reinforcing alcohol abstinence. Individuals with frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld breathalyzer for one month. Participants will be randomized to one of two conditions: alcohol monitoring or alcohol monitoring plus contingency management. In both conditions, research assistants will telephone participants on their cell phone an average of 10 times per week to request submission of a breathalyzer sample using the video monitoring function on the cell phone. Samples will be time and date stamped, and the video containing the breathalyzer result will be sent to study staff via the cell phone. Participants will be compensated for each video recorded within one hour of receiving the prompt. Participants randomized to the contingency management condition will receive the same alcohol monitoring described above, and they will also receive reinforcement for each alcohol negative breath sample submitted within one hour of the prompt. Data from this pilot project will be useful for (1) determining the feasibility of assessing alcohol use in the natural environment via breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM intervention that reinforces alcohol abstinence using breathalyzers and cell phone technology. In an exploratory manner, we will also evaluate the reliability and validity of the video monitoring procedure and trends toward changes in psychosocial functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monitoring Alone
Arm Type
No Intervention
Arm Description
Research assistants will phone or text participants and request videorecordings of breathalyzer samples up to 21 times per week. Participants will receive compensation for each valid videorecording that occurs within the requested one-hour time frame, and bonus compensation each time all requested videorecordings are submitted within the timeframe over a 7-day period, and/or if >90% of prompts are returned over the study period.
Arm Title
Monitoring plus contingency management for abstinence
Arm Type
Experimental
Arm Description
Participants assigned to this condition will receive the same monitoring schedule outlined above, plus the same payment for compliance. In addition, they will receive contingent reinforcement for submission of videorecordings that demonstrate negative breath alcohol samples. For each sample submitted that reads below the cut point, participants will receive vouchers for payment.
Intervention Type
Behavioral
Intervention Name(s)
contingency management for abstinence
Intervention Description
For each breath sample submitted that reads below the cut point, participants will receive a voucher that can be exchanged for a check or gift card. Amounts earned will increase for each consecutive negative sample submitted, up to a maximum amount.
Primary Outcome Measure Information:
Title
proportion of negative breath samples submitted
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >21 years frequent alcohol use willing to use a cell phone and breathalyzer for 28 days have a valid photo ID (driver's license, passport, state ID) are willing to sign an off-campus property transfer form and return study equipment in four weeks Exclusion Criteria: desire for, or have received, treatment for alcohol use in the past 6 months non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Alessi, Ph.D.
Organizational Affiliation
University of Conncecticut Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-3944
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23279560
Citation
Alessi SM, Petry NM. A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. Addiction. 2013 May;108(5):900-9. doi: 10.1111/add.12093. Epub 2013 Jan 30.
Results Reference
derived

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Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

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