Web-based Addiction Treatment: Cultural Adaptation With American Indians

Substance Use Disorders Clinical Trial

Official title:

Web-based Addiction Treatment: Cultural Adaptation With American Indians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363256
• Other study ID #: #7555
• Secondary ID: R34DA040831
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives [AI/AN]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Identify as American Indian or Alaska Native

• Recent alcohol or drug use

• Within first 30 days of current outpatient treatment episode

Exclusion Criteria:

• Planned treatment episode of less than 3 months

• Insufficient ability to provide informed consent

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• TES-NAV
Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN
• TAU
Standard outpatient addiction treatment

Locations

Country	Name	City	State
United States	Native American Rehabilitation Association of the Northwest, Inc.	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055. Erratum in: Am J Psychiatry. 2014 Dec 1;171(12):1338. — View Citation

Campbell AN, Turrigiano E, Moore M, Miele GM, Rieckmann T, Hu MC, Kropp F, Ringor-Carty R, Nunes EV. Acceptability of a web-based community reinforcement approach for substance use disorders with treatment-seeking American Indians/Alaska Natives. Community Ment Health J. 2015 May;51(4):393-403. doi: 10.1007/s10597-014-9764-1. Epub 2014 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consecutive weeks of drug/alcohol abstinence	Number of consecutive weeks of abstinence from drugs and alcohol	12 weeks