Substance Use DisordersNCT03363256
Web-based Addiction Treatment: Cultural Adaptation With American Indians
A study testing TES-NAV and TAU in people with Substance Use Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- TES-NAV and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planned treatment episode of less than 3 months
- Insufficient ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Native American Rehabilitation Association of the Northwest, Inc.
Portland, Oregon, 97205
About this study
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.
- Conditions
- Substance Use Disorders
- Being tested
- TES-NAV, TAU
- Keywords
- Digital therapeutics, Adaptation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TES-NAVBehavioural
Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN
TAUBehavioural
Standard outpatient addiction treatment
| Study group | Role | What they receive |
|---|---|---|
| TAU+TES-NAV | Experimental | Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN Receives: Behavioral: TES-NAV; Behavioral: TAU |
| TAU | Active comparator | Standard outpatient addiction treatment Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks (following randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start30 May 2018
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Aimee Campbell, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363256
- Sponsor's protocol ID
- #7555
- Other IDs
- R34DA040831
- Status last verified
- May 2026
- First submitted
- 30 Nov 2017
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37690525
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Addiction Treatment: Cultural Adaptation With American Indians
- ClinicalTrials.gov ID
- NCT03363256
- Acronym / sponsor ID
- #7555
- Conditions
- Substance Use Disorders
- Keywords
- Digital therapeutics, Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU+TES-NAV | Experimental | Behavioral: TES-NAV, Behavioral: TAUStandard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN |
| TAU | Active comparator | Behavioral: TAUStandard outpatient addiction treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Planned treatment episode of less than 3 months
- Insufficient ability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TES-NAVInternet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN | Behavioural | TAU+TES-NAV |
| TAUStandard outpatient addiction treatment | Behavioural | TAU, TAU+TES-NAV |
Primary outcome
Consecutive Weeks of Drug/Alcohol Abstinence
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37690525Campbell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TES-NAV and TAU in people with Substance Use Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consecutive Weeks of Drug/Alcohol Abstinence (time frame: 12 weeks (following randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.