Clinical trial NCT01104805: Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders
Official title: NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Drug Abuse
Substance Abuse
Substance Use Disorder
Addiction
Behavioral Treatment
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-04-15
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment.

Detailed description: The principal objective of the planned trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment. CRA is a cognitive-behavioral intervention which seeks to give patients skills to achieve and maintain abstinence and improve social functioning and is often paired with contingency management, where patients earn rewards contingent upon drug negative urines. CRA is an intensive treatment, generally delivered in individual sessions 2 to 3 times per week. Thus, it is expensive and time-consuming to deliver, to train clinical staff, and to provide supervision to maintain clinical staff skill. However, because CRA is oriented toward knowledge and skills, it lends itself to being delivered by computer, using computer-interactive learning technologies.

Individuals accepted into community-based outpatient treatment for substance use disorders (excluding those receiving opioid pharmacotherapy for opioid dependence) will be eligible to participate. This is a multi-site, controlled trial, using NIDA's Clinical Trials Network platform, at approximately 10 Community Treatment Programs, in which participants (N = approximately 500) will be randomized to receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating treatment programs in which participants are enrolled, or (2) a modification of TAU which includes access to the TES. It is hypothesized that access to TES will improve substance use outcome and retention in outpatient treatment.

Computer interactive interventions like TES have the potential to deliver science-based psychosocial treatments with high fidelity and cost-effectiveness while conserving clinician time to focus on monitoring and addressing patients' needs. If found to be effective, TES could substantially advance the substance abuse treatment system by improving quality of care delivered, increasing availability of treatment slots by extending and leveraging the efforts of clinical staff, and projecting treatment to rural and other underserved areas.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, 18 years or older, accepted for outpatient, substance abuse treatment at a participating study site.
* Self-report any substance use problem (including alcohol, as long as they also report other drug use in addition to alcohol).
* Self-report recent drug use.
* Within 30 days of initiating treatment at a collaborating study site.
* Self-report a planned substance abuse treatment episode of at least 3 months.

Exclusion Criteria:

* Receiving opioid replacement medication.
* Plan to move out of the area within the next 3 months.
* Insufficient ability to provide informed consent.
* Insufficient ability to use English to participate meaningfully in the consent process, the interventions or research assessments.

Primary outcomes:
measure: Reduced Substance Use and Improved Treatment Retention
timeFrame: 12-week Treatment Phase
Secondary outcomes:
measure: Effectiveness
timeFrame: 12-week treatment phase, 3- and 6-months post treatment
measure: Sustained outcome
timeFrame: 3- and 6-months post treatment
measure: Economic Analysis
timeFrame: 12-week treatment phase, 3- and 6-months post treatment
measure: Coping Skills
timeFrame: 12-week treatment phase, 3- and 6-months post treatment
Other outcomes:
Locations:
city: Danbury
country: United States
facility: MCCA: Midwestern CT Council on Alcoholism
state: Connecticut
city: Orlando
country: United States
facility: The Center for Drug Free Living
state: Florida
city: Waipahu
country: United States
facility: Hina Mauka
state: Hawaii
city: Indianapolis
country: United States
facility: Midtown Community Mental Health Center
state: Indiana
city: Baltimore
country: United States
facility: HARBEL Prevention and Recovery Center
state: Maryland
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources (SSTAR)
state: Massachusetts
city: West Hempstead
country: United States
facility: Project Outreach
state: New York
city: Eugene
country: United States
facility: Willamette Family, Inc.
state: Oregon
city: Dallas
country: United States
facility: Homeward Bound
state: Texas
city: Everett
country: United States
facility: Evergreen Manor
state: Washington
Study officials:
affiliation: NIDA Clinical Trials Network - Long Island Regional Node
name: Edward V Nunes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luderer HF, Campbell ANC, Nunes EV, Enman NM, Xiong X, Gerwien R, Maricich YA. Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes. J Subst Abuse Treat. 2022 Jan;132:108585. doi: 10.1016/j.jsat.2021.108585. Epub 2021 Jul 30.
citation: Murphy SM, Campbell AN, Ghitza UE, Kyle TL, Bailey GL, Nunes EV, Polsky D. Cost-effectiveness of an internet-delivered treatment for substance abuse: Data from a multisite randomized controlled trial. Drug Alcohol Depend. 2016 Apr 1;161:119-26. doi: 10.1016/j.drugalcdep.2016.01.021. Epub 2016 Jan 30.
citation: Cochran G, Stitzer M, Campbell AN, Hu MC, Vandrey R, Nunes EV. Web-based treatment for substance use disorders: differential effects by primary substance. Addict Behav. 2015 Jun;45:191-4. doi: 10.1016/j.addbeh.2015.02.002. Epub 2015 Feb 8.
citation: Mitchell SG, Schwartz RP, Alvanzo AA, Weisman MS, Kyle TL, Turrigiano EM, Gibson ML, Perez L, McClure EA, Clingerman S, Froias A, Shandera DR, Walker R, Babcock DL, Bailey GL, Miele GM, Kunkel LE, Norton M, Stitzer ML. The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study. Subst Abus. 2015;36(4):420-6. doi: 10.1080/08897077.2014.992565. Epub 2015 Feb 11.
citation: Cochran G, Stitzer M, Nunes EV, Hu MC, Campbell A. Clinically relevant characteristics associated with early treatment drug use versus abstinence. Addict Sci Clin Pract. 2014 Apr 4;9(1):6. doi: 10.1186/1940-0640-9-6.