NCT03363256

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

November 30, 2017

Results QC Date

April 24, 2026

Last Update Submit

May 15, 2026

Conditions

Substance Use Disorders

Keywords

Digital therapeuticsAdaptation

Outcome Measures

Primary Outcomes (1)

  • Consecutive Weeks of Drug/Alcohol Abstinence

    Each week was categorized as abstinent if the urine screen was negative and the self-report indicated no drug use and no heavy drinking days and not abstinent if either urine screen or self-report indicated drug use or heavy drinking. If the urine screen was missing, TLFB self-report data was used.

    12 weeks (following randomization)

Study Arms (2)

TAU+TES-NAV

EXPERIMENTAL

Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN

Behavioral: TES-NAVBehavioral: TAU

TAU

ACTIVE COMPARATOR

Standard outpatient addiction treatment

Behavioral: TAU

Interventions

TES-NAVBEHAVIORAL

Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN

TAU+TES-NAV
TAUBEHAVIORAL

Standard outpatient addiction treatment

TAUTAU+TES-NAV

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Planned treatment episode of less than 3 months
  • Insufficient ability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Native American Rehabilitation Association of the Northwest, Inc.

Portland, Oregon, 97205, United States

Location

Related Publications (1)

  • Campbell ANC, Rieckmann T, Pavlicova M, Choo TH, Molina K, McDonell M, West AE, Daw R, Marsch LA, Venner KL. Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study. J Subst Use Addict Treat. 2023 Dec;155:209159. doi: 10.1016/j.josat.2023.209159. Epub 2023 Sep 9.

    PMID: 37690525RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Aimee Campbell, PhD
Organization
New York State Psychiatric Institute
anc2002@cumc.columbia.edu
646-774-6138

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Professor of Clinical Psychiatric Social Work

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

May 30, 2018

Primary Completion

June 30, 2020

Study Completion

September 30, 2020

Last Updated

May 19, 2026

Results First Posted

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)