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Web-based Addiction Treatment: Cultural Adaptation With American Indians

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ClinicalTrials.gov Identifier: NCT03363256
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee N. C. Campbell, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: TES-NAV Behavioral: TAU Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-based Addiction Treatment: Cultural Adaptation With American Indians
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: TAU+TES-NAV
Standard outpatient addiction treatment plus Therapeutic Education System adapted for AI/AN
Behavioral: TES-NAV
Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN

Behavioral: TAU
Standard outpatient addiction treatment

Active Comparator: TAU
Standard outpatient addiction treatment
Behavioral: TAU
Standard outpatient addiction treatment




Primary Outcome Measures :
  1. Consecutive weeks of drug/alcohol abstinence [ Time Frame: 12 weeks ]
    Number of consecutive weeks of abstinence from drugs and alcohol



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363256


Contacts
Contact: Aimee Campbell, PhD 646-774-6138 anc2002@cumc.columbia.edu
Contact: Traci Rieckmann, PhD traci.rieckmann@greenfieldhealth.com

Locations
United States, Oregon
Native American Rehabilitation Association of the Northwest, Inc. Recruiting
Portland, Oregon, United States, 97205
Contact: Roz Ringor-Carty, MSW       RRingor@NaraNorthwest.org   
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)

Publications:
Responsible Party: Aimee N. C. Campbell, Associate Professor of Clinical Psychiatric Social Work, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03363256     History of Changes
Other Study ID Numbers: #7555
R34DA040831 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aimee N. C. Campbell, New York State Psychiatric Institute:
Digital therapeutics
Adaptation

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders