NCT01307345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

February 28, 2011

Last Update Submit

July 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • proportion of negative breath samples submitted

    Week 4

Study Arms (2)

Monitoring Alone

NO INTERVENTION

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.

Monitoring plus contingency management for abstinence

EXPERIMENTAL

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

Interventions

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.

Monitoring plus contingency management for abstinence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3944, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Sheila Alessi, Ph.D.

    University of Conncecticut Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations