Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

Sponsor

UConn Health (Other)

Overall Status

Completed

CT.gov ID

NCT01307345

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use	Behavioral: contingency management for abstinence	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Monitoring Alone 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.
Experimental: Monitoring plus contingency management for abstinence 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.	Behavioral: contingency management for abstinence 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.

Arm

Intervention/Treatment

No Intervention: Monitoring Alone

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.

Experimental: Monitoring plus contingency management for abstinence

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.

Behavioral: contingency management for abstinence

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.

Outcome Measures

Primary Outcome Measures

proportion of negative breath samples submitted [Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Connecticut Health Center	Farmington	Connecticut	United States	06030-3944

Sponsors and Collaborators

UConn Health
National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Sheila Alessi, Ph.D., University of Conncecticut Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UConn Health

ClinicalTrials.gov Identifier:

NCT01307345

Other Study ID Numbers:

11-058-1
P30DA023918

First Posted:

Mar 2, 2011

Last Update Posted:

Jul 20, 2018

Last Verified:

Jul 1, 2018

Additional relevant MeSH terms:

Alcohol Abstinence

Study Results

No Results Posted as of Jul 20, 2018