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Deposit Contracts to Increase Accessibility of a Contingency Management Intervention to Reduce Problematic Drinking

Primary Purpose

Alcohol Abuse, Alcohol Intervention, Transdermal Alcohol Monitoring

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deposit Contract
Transdermal Alcohol Monitoring
Sponsored by
University of North Texas, Denton, TX
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

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

Inclusion Criteria: at least 21 years of age report > 8 heavy drinking episodes during the last 28 days want to reduce their alcohol use are willing to wear a transdermal alcohol monitor own a smartphone are willing and able to deposit $200

Sites / Locations

  • University Of North TexasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Monitoring Group Only

Deposit Contract Group

Arm Description

Individuals in the Monitoring only group will be required to put down a 200$ deposit but will earn it back non-contingently by attending the weekly study meetings. They will be monitored using the Transdermal Alcohol Monitoring device, but will not be required to meet any Alcohol reduction goals to earn their deposit back.

Individuals in the Deposit COntract group will be required to put down a 200$ deposit but will earn it back, as well as a bonus, contingently for meeting alcohol reduction requirements. For this study, this is counted as having a Transdermal Alcohol COntent below equal to .02 g/dl. They will be monitored using the Transdermal Alcohol Monitoring device.

Outcomes

Primary Outcome Measures

Transdermal Alcohol Content
Measurement produced while wearing Transdermal Alcohol Monitor

Secondary Outcome Measures

Full Information

First Posted
April 19, 2023
Last Updated
May 3, 2023
Sponsor
University of North Texas, Denton, TX
Collaborators
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT05837611
Brief Title
Deposit Contracts to Increase Accessibility of a Contingency Management Intervention to Reduce Problematic Drinking
Official Title
Piloting Deposit Contracts to Increase Accessibility of a Contingency Management Intervention to Reduce Problematic Drinking
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Texas, Denton, TX
Collaborators
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the effects of an incentive-based intervention (for reducing alcohol use) that would be sustainable, easily accessible intervention using remote alcohol monitoring and deposit contracts, targeting individuals who would not be reached by more traditional forms of treatment due to barriers such as time constraints, attitudes, and stigma.
Detailed Description
Deposit contracts are effective at treating a wide variety of problems: smoking cessation, weight loss, and increasing physical activity. Despite the promise of deposit contracts, few earlier studies targeted problem drinking, since doing so required burdensome frequent monitoring - now overcome by remote alcohol monitoring. Earlier work relied on self- and collateral reports, breath alcohol concentrations during clinic visits, or an indirect non-specific marker of alcohol use. Despite these difficulties, earlier studies of deposit contracts were encouraging, with notable increases in: therapy participation; retention ; and abstinence duration compared to previous reports. Collectively, these studies show the potential of deposit contracts to reduce problem drinking but provide only limited evidence of its effectiveness. Still, these studies, and our recent success using contingency management with remote alcohol monitoring, provide a compelling rationale for examining whether a deposit contract program might provide a feasible, effective, and accessible way of helping people reduce drinking. Though there is limited systematic research on deposit contracts, deposit contract programs for various problems are widely available and have proven quite attractive. For example, a deposit contract weight loss website, has over 887,000 users with $62M in incentives paid. However, it is unclear if deposit contracts would be acceptable (and therefore feasible) to individuals interested in reducing their problem drinking. Therefore, we feel that the proposed deposit contract intervention utilizing remote alcohol monitoring could be a widely available and acceptable intervention for problem drinking for three reasons: (1) because of the effectiveness and convenience of our contingency management intervention using remote alcohol monitoring; (2) because of the widespread success of other deposit contract programs like DietBetã; and (3) because the potentially increased attractiveness and effectiveness of an intervention that can return an amount greater than the deposit. The adoption of a deposit contract intervention plus remote alcohol monitoring will only be accelerated by the "FitBit"-style alcohol monitoring devices being developed by many companies (we are currently independently evaluating one such device). However, making deposit contracts widely available will need evidence of their effectiveness, which requires large randomized controlled trials. The purpose of this R21 application is to develop this evidence by demonstrating that deposit contracts with remote alcohol monitoring are feasible and provide evidence of effectiveness needed to design and justify future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Intervention, Transdermal Alcohol Monitoring, Contingency Management, Deposit Contract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitoring Group Only
Arm Type
Active Comparator
Arm Description
Individuals in the Monitoring only group will be required to put down a 200$ deposit but will earn it back non-contingently by attending the weekly study meetings. They will be monitored using the Transdermal Alcohol Monitoring device, but will not be required to meet any Alcohol reduction goals to earn their deposit back.
Arm Title
Deposit Contract Group
Arm Type
Experimental
Arm Description
Individuals in the Deposit COntract group will be required to put down a 200$ deposit but will earn it back, as well as a bonus, contingently for meeting alcohol reduction requirements. For this study, this is counted as having a Transdermal Alcohol COntent below equal to .02 g/dl. They will be monitored using the Transdermal Alcohol Monitoring device.
Intervention Type
Behavioral
Intervention Name(s)
Deposit Contract
Intervention Description
A deposit contract requires individuals to put down money that is earned back contingently upon meeting their goals.
Intervention Type
Other
Intervention Name(s)
Transdermal Alcohol Monitoring
Intervention Description
Using a SCRAM-Cam device participants will be monitored for their alcohol use.
Primary Outcome Measure Information:
Title
Transdermal Alcohol Content
Description
Measurement produced while wearing Transdermal Alcohol Monitor
Time Frame
4 weeks continuously

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 21 years of age report > 8 heavy drinking episodes during the last 28 days want to reduce their alcohol use are willing to wear a transdermal alcohol monitor own a smartphone are willing and able to deposit $200
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie R Pogue
Phone
9403698308
Email
Jamie.pogue@unt.edu
Facility Information:
Facility Name
University Of North Texas
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie R Pogue, BA
Phone
940-369-8308
Email
Jamie.Pogue@unt.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
971213
Citation
Bigelow G, Strickler D, Liebson I, Griffiths R. Maintaining disulfiram ingestion among outpatient alcoholics: a security-deposit contingency contracting procedure. Behav Res Ther. 1976;14(5):378-81. doi: 10.1016/0005-7967(76)90028-0. No abstract available.
Results Reference
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PubMed Identifier
29671957
Citation
Burns RJ, Rothman AJ. Comparing Types of Financial Incentives to Promote Walking: An Experimental Test. Appl Psychol Health Well Being. 2018 Jul;10(2):193-214. doi: 10.1111/aphw.12126. Epub 2018 Apr 19.
Results Reference
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PubMed Identifier
31976444
Citation
Dallery J, Raiff BR, Grabinski MJ, Marsch LA. Technology-Based Contingency Management in the Treatment of Substance-Use Disorders. Perspect Behav Sci. 2019 Jul 9;42(3):445-464. doi: 10.1007/s40614-019-00214-1. eCollection 2019 Sep.
Results Reference
background
PubMed Identifier
7316923
Citation
Ersner-Hershfield SM, Connors GJ, Maisto SA. Clinical and experimental utility of refundable deposits. Behav Res Ther. 1981;19(5):455-7. doi: 10.1016/0005-7967(81)90137-6. No abstract available.
Results Reference
background
PubMed Identifier
28211949
Citation
Jarvis BP, Dallery J. Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. J Appl Behav Anal. 2017 Apr;50(2):189-205. doi: 10.1002/jaba.377. Epub 2017 Feb 17.
Results Reference
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PubMed Identifier
7369987
Citation
Paxton R. The effects of a deposit contract as a component in a behavioural programme for stopping smoking. Behav Res Ther. 1980;18(1):45-50. doi: 10.1016/0005-7967(80)90068-6. No abstract available.
Results Reference
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PubMed Identifier
756475
Citation
Pomerleau O, Pertschuk M, Adkins D, Brady JP. A comparison of behavioral and traditional treatment for middle-income problem drinkers. J Behav Med. 1978 Jun;1(2):187-200. doi: 10.1007/BF00846639.
Results Reference
background
PubMed Identifier
19066383
Citation
Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
Results Reference
background
PubMed Identifier
24139765
Citation
White JS, Dow WH, Rungruanghiranya S. Commitment contracts and team incentives: a randomized controlled trial for smoking cessation in Thailand. Am J Prev Med. 2013 Nov;45(5):533-42. doi: 10.1016/j.amepre.2013.06.020.
Results Reference
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Deposit Contracts to Increase Accessibility of a Contingency Management Intervention to Reduce Problematic Drinking

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