Back to resultsWeb-based Addiction Treatment: Cultural Adaptation With American Indians
Primary Purpose
Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TES-NAV
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Digital therapeutics, Adaptation
Eligibility Criteria
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
Sites / Locations
- Native American Rehabilitation Association of the Northwest, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TAU+TES-NAV
TAU
Arm Description
Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN
Standard outpatient addiction treatment
Outcomes
Primary Outcome Measures
Consecutive weeks of drug/alcohol abstinence
Number of consecutive weeks of abstinence from drugs and alcohol
Secondary Outcome Measures
Full Information
NCT ID
NCT03363256
First Posted
November 30, 2017
Last Updated
November 11, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03363256
Brief Title
Web-based Addiction Treatment: Cultural Adaptation With American Indians
Official Title
Web-based Addiction Treatment: Cultural Adaptation With American Indians
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Digital therapeutics, Adaptation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU+TES-NAV
Arm Type
Experimental
Arm Description
Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Standard outpatient addiction treatment
Intervention Type
Behavioral
Intervention Name(s)
TES-NAV
Intervention Description
Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Standard outpatient addiction treatment
Primary Outcome Measure Information:
Title
Consecutive weeks of drug/alcohol abstinence
Description
Number of consecutive weeks of abstinence from drugs and alcohol
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Native American Rehabilitation Association of the Northwest, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25022913
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.
Results Reference
background
PubMed Identifier
24700332
Citation
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.
Results Reference
background
Learn more about this trial
Web-based Addiction Treatment: Cultural Adaptation With American Indians
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