NCT02135237

Brief Summary

Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

5.4 years

First QC Date

February 24, 2014

Last Update Submit

October 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • longest duration of abstinence from alcohol

    objective report of alcohol use as measured by SCRAMx device

    three months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standard Care

Behavioral: Standard Care

Experimental Group

EXPERIMENTAL

Standard Care plus Prize Contingency Management for Alcohol Abstinence

Behavioral: Prize Contingency Management for Alcohol AbstinenceBehavioral: Standard Care

Interventions

The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors

Experimental Group
Standard CareBEHAVIORAL
Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older
  • current diagnosis of alcohol use disorder and self report of recent alcohol use
  • 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 weekly for brief research visits/downloads
  • agree to sign an off-campus property transfer form and return SCRAMx equipment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Hospital of Central Connecticut at New Britain General

New Britain, Connecticut, 06050, United States

Location

Farrell Treatment Center

New Britain, Connecticut, 06051, United States

Location

Behavioral Health Network, Inc.

Springfield, Massachusetts, 01104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolStandard of Care

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sheila Alessi, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2014

First Posted

May 9, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations