Trial Outcomes & Findings for Web-based Addiction Treatment: Cultural Adaptation With American Indians (NCT NCT03363256)

Last Updated: 2026-05-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

12 weeks (following randomization)

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	TAU + TES-NAV (Digital Intervention) Standard outpatient psychosocial treatment for alcohol and drug use disorder at the study site (Treatment as Usual or TAU) plus Therapeutic Education System (digital intervention CRA + CM) adapted for AI/AN	TAU (Standard Outpatient Addiction Treatment) Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU).
Overall Study STARTED	27	26
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Web-based Addiction Treatment: Cultural Adaptation With American Indians

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAU + TES-NAV (Digital Intervention) n=27 Participants Standard outpatient psychosocial treatment for alcohol and drug use disorder at the study site (Treatment as Usual or TAU) plus Therapeutic Education System (digital intervention CRA + CM) adapted for AI/AN.	TAU (Standard Outpatient Addiction Treatment) n=26 Participants Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU).	Total n=53 Participants Total of all reporting groups
Age, Continuous	37.0 Years STANDARD_DEVIATION 10.2 • n=30 Participants	40.2 Years STANDARD_DEVIATION 10.3 • n=30 Participants	38.6 Years STANDARD_DEVIATION 10.3 • n=60 Participants
Sex/Gender, Customized Female	12 Participants n=30 Participants	12 Participants n=30 Participants	24 Participants n=60 Participants
Sex/Gender, Customized Male	14 Participants n=30 Participants	14 Participants n=30 Participants	28 Participants n=60 Participants
Sex/Gender, Customized Other	1 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	23 Participants n=30 Participants	19 Participants n=30 Participants	42 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	1 Participants n=30 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) White	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Race (NIH/OMB) More than one race	4 Participants n=30 Participants	6 Participants n=30 Participants	10 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=30 Participants	4 Participants n=30 Participants	6 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=30 Participants	22 Participants n=30 Participants	47 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants

PRIMARY outcome

Timeframe: 12 weeks (following randomization)

Outcome measures

Outcome measures
Measure	TAU + TES-NAV (Digital Intervention) n=27 Participants Standard outpatient psychosocial treatment for alcohol and drug use disorder at the study site (Treatment as Usual or TAU) plus Therapeutic Education System (digital intervention CRA + CM) adapted for AI/AN.	TAU (Standard Outpatient Addiction Treatment) n=26 Participants Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU).
Consecutive Weeks of Drug/Alcohol Abstinence	2.0 Weeks Interval 1.0 to 11.0	2.0 Weeks Interval 1.0 to 6.0

Adverse Events

TAU + TES-NAV (Digital Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAU (Standard Outpatient Addiction Treatment)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TAU + TES-NAV (Digital Intervention) n=27 participants at risk Standard outpatient psychosocial treatment for alcohol and drug use disorder at the study site (Treatment as Usual or TAU) plus Therapeutic Education System (digital intervention CRA + CM) adapted for AI/AN.	TAU (Standard Outpatient Addiction Treatment) n=26 participants at risk Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU).
Injury, poisoning and procedural complications Suicide attempt	0.00% 0/27 • From enrollment until the end of follow up (on average 24 weeks)	3.8% 1/26 • From enrollment until the end of follow up (on average 24 weeks)

Other adverse events

Adverse event data not reported

Additional Information

Aimee Campbell, PhD

New York State Psychiatric Institute

Phone: 646-774-6138

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place