Motivational Incentives for Alcohol Abstinence in America... | NCT02174315

Studies
Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults

NCT02174315

Sponsor

Washington State University

Status

Completed

Last Update Posted

May 1, 2023Actual

Enrollment

400Actual

Phase

Not Applicable

Conditions

Alcohol Abuse

Interventions

Contingency Management

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

Status Module

Record Verification Date

Apr 2023

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

Oct 1, 2014

Primary Completion Date

Sep 9, 2019Actual

Completion Date

Sep 9, 2019Actual

First Submitted Date

May 13, 2014

First Submission Date that Met QC Criteria

Jun 24, 2014

First Posted Date

Jun 25, 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

Apr 27, 2023

Last Update Posted Date

May 1, 2023Actual

Description Module

Brief Summary

This study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Contingency Management	Experimental		Behavioral: Contingency Management
Non-Contingent Control Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Contingency Management	Behavioral		Contingency Management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in alcohol use as assessed by ethyl glucuronide detection in urine		Twice weekly for twelve weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self reported American Indian/Alaskan Native
Current alcohol dependence
5 or more standard drink on 1 or more occasions in the last 30 days
Ability to read and speak English
Ability to provide written informed consent

Exclusion Criteria:

Illicit drug use greater than alcohol use in the last 90 days
A risk of dangerous alcohol withdrawal
Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder

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
Michael McDonell, PhD	Washington State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact PI		Pullman	Washington		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37267179	Derived	Hirchak KA, Kordas G, Lyons AJ, Herron J, Jansen K, Shaw J, McPherson SM, Roll J, Buchwald D, McDonell MG; HONOR Study Team. Investigating Secondary Alcohol Outcomes in a Contingency Management Intervention among American Indian and Alaska Native Adults. J Addict Med. 2023 May-Jun 01;17(3):e177-e182. doi: 10.1097/ADM.0000000000001116. Epub 2022 Dec 21.
34952747

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