Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01307345
First received: February 28, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Alcohol Use
Behavioral: contingency management for abstinence
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • proportion of negative breath samples submitted [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307345

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3944
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Sheila Alessi, Ph.D. University of Conncecticut Health Center
  More Information

No publications provided by University of Connecticut Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01307345     History of Changes
Other Study ID Numbers: 11-058-1, P30DA023918
Study First Received: February 28, 2011
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Abstinence
Drinking Behavior

ClinicalTrials.gov processed this record on October 21, 2014