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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA040831 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU+TES-NAV | Experimental | Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN |
|
| TAU | Active Comparator | Standard outpatient addiction treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TES-NAV | Behavioral | Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Native American Rehabilitation Association of the Northwest, Inc. | Portland | Oregon | 97205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37690525 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | TAU (Standard Outpatient Addiction Treatment) | Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | TAU (Standard Outpatient Addiction Treatment) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Weeks | 12 weeks (following randomization) |
|
From enrollment until the end of follow up (on average 24 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Injury, poisoning and procedural complications | Systematic Assessment | Not related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimee Campbell, PhD | New York State Psychiatric Institute | 646-774-6138 | anc2002@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2019 | Apr 24, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2017 | Apr 24, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| TAU | Behavioral | Standard outpatient addiction treatment |
|
Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU).
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | TAU (Standard Outpatient Addiction Treatment) | Standard outpatient psychosocial treatment for alcohol and drug use disorder (Treatment as Usual or TAU). | 0 | 26 | 1 | 26 | 0 | 26 |
|
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