CM Treatment for Alcohol Dependence Using New Technology | NCT02143037

Studies
CM Treatment for Alcohol Dependence Using New Technology

NCT02143037

Sponsor

UConn Health

Status

Completed

Last Update Posted

May 17, 2019Actual

Enrollment

114Actual

Phase

Not Applicable

Conditions

Alcohol Use Disorder
Contingency Management

Interventions

prize contingency management for attending treatment
usual care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P60AA003510	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013Actual

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

May 19, 2014

First Posted Date

May 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2019

Last Update Posted Date

May 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheila Alessi, Associate Professor, UConn HealthPrincipal Investigator

Lead Sponsor

UConn HealthOTHER

Collaborators

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Contingency management (CM) is highly efficacious for reducing substance use, and recent data suggest that reinforcing attendance at treatment can significantly improve treatment outcomes. Importantly, CM interventions that reinforce attendance are more likely to be adopted clinically than those that reinforce abstinence. Having objective indicators of drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for objective evaluation of alcohol consumption during treatment intervention studies, including those that involve CM.

In this study, 114 patients participating in community based outpatient treatment programs for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to standard care or standard care plus CM, with reinforcement contingent upon attendance at treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and self reports. The investigators expect that patients randomized to the CM intervention will remain in treatment longer and show reductions in both SCRAMx assessed and self reported drinking days relative to those randomized to standard care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Active Comparator	usual care	Behavioral: usual care
Experimental Group	Experimental	usual care plus prize contingency management for attending treatment	Behavioral: prize contingency management for attending treatment Behavioral: usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
prize contingency management for attending treatment	Behavioral		Experimental Group
usual care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
longest duration of actively attending treatment	patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18 years or older
current diagnosis of alcohol use disorder
able to pass an informed consent quiz
agree to wear a SCRAMx monitor for 12 weeks
have a standard, SCRAMx compatible phone line in their home or agree to attend the clinic at least every other week for data downloads
agree to sign an off-campus property transfer form and return SCRAMx equipment in 12 weeks

Exclusion Criteria:

serious, uncontrolled psychiatric illness
in recovery from pathological gambling
unstable address
intend to participate in activities incompatible with SCRAMx in the next 3 months
are wearing SCRAMx for legal purposes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sheila M Alessi, Ph.D.	UConn Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional Network of Programs, Inc.		Bridgeport	Connecticut	06610	United States
Alcohol and Drug Recovery Centers, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided