Substance Use Disorders
Conditions
Keywords
Digital therapeutics, Adaptation
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.
Interventions
BEHAVIORALTES-NAV
Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN
BEHAVIORALTAU
Standard outpatient addiction treatment
Sponsors
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consecutive Weeks of Drug/Alcohol Abstinence | 12 weeks (following randomization) | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.6 Years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 42 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex/Gender, Customized Female | 12 Participants |
| Sex/Gender, Customized Male | 14 Participants |
| Sex/Gender, Customized Other | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 1 / 26 |
Outcome results
None listed