Substance AbuseCTN-0044NCT01104805
Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders
A study testing Therapeutic Education System (TES) and Treatment-as-Usual (TAU) in people with Substance Abuse, run by New York State Psychiatric Institute at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Therapeutic Education System (TES) and Treatment-as-Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
HARBEL Prevention and Recovery Center
Baltimore, Maryland, 21214
Homeward Bound
Dallas, Texas, 75208
MCCA: Midwestern CT Council on Alcoholism
Danbury, Connecticut, 06810
Willamette Family, Inc.
Eugene, Oregon, 97402
Evergreen Manor
Everett, Washington, 98201
Stanley Street Treatment and Resources (SSTAR)
Fall River, Massachusetts, 02720
Midtown Community Mental Health Center
Indianapolis, Indiana, 46208
The Center for Drug Free Living
Orlando, Florida, 32856
Hina Mauka
Waipahu, Hawaii, 96797
Project Outreach
West Hempstead, New York, 11552
About this study
Official title: NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)
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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Therapeutic Education System (TES), Treatment-as-Usual (TAU)
- Keywords
- Drug Abuse, Substance Abuse, Substance Use Disorder, Addiction, Behavioral Treatment
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education System (TES)Behavioural
Also called Therapeutic Education System, TES
Participants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.
Treatment-as-Usual (TAU)Behavioural
Also called Treatment as Usual, TAU, Standard Treatment
Participants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education System (TES) | Experimental | Participants randomized to this arm will replace approximately 2 hours of Standard Treatment with the Therapeutic Education System (TES) (comprised of a web-based version of the Community Reinforcement Approach and contingency management). Receives: Behavioral: Therapeutic Education System (TES) |
| Treatment-as-Usual (TAU) | Other | Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program. Receives: Behavioral: Treatment-as-Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Substance Use and Improved Treatment Retention
Compared to patients assigned to Treatment as Usual (TAU), patients assigned to modified TAU plus the Therapeutic Education System (Modified TAU + TES) will have:
- reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and
- better retention in treatment at their community-based treatment programs.
Measured: 12-week Treatment Phase
Secondary outcomes (4)
Effectiveness
To evaluate the relative effectiveness of TAU vs. modified TAU + TES on several secondary outcome measures, including measures of HIV risk behavior, psychosocial functioning (in areas of criminal activity, health status improvement, psychological status, family/social relationships, and employment, and treatment acceptability (based on participant feedback).
Measured: 12-week treatment phase, 3- and 6-months post treatment
Sustained outcome
To evaluate if improved substance use and retention outcomes are maintained 3- and 6-months post-intervention.
Measured: 3- and 6-months post treatment
Economic Analysis
To perform a comprehensive economic analysis of including TES in TAU to inform decisions regarding adoption of this new therapeutic tool (assessing incremental costs per increased abstinence time and quality adjusted life year). The economic analyses are clinically important, as even if the computerized intervention is shown to be effective, it may not be adopted in community-based treatment programs unless it is shown to be cost-effective due to the considerable financial constraints in such treatment settings.
Measured: 12-week treatment phase, 3- and 6-months post treatment
Coping Skills
To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.
Measured: 12-week treatment phase, 3- and 6-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- 507 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
- Sponsor
- Investigators
- Edward V Nunes, MD, Principal investigator, NIDA Clinical Trials Network - Long Island Regional Node
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104805
- Sponsor's protocol ID
- NYSPI #6051
- Other IDs
- U10DA013035, NIDA-CTN-0044
- Acronym
- CTN-0044
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2010
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34366201Murphy 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.
PubMed 26880594Cochran 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.
PubMed 25697725Mitchell 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.
PubMed 25671593Cochran 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.
PubMed 24708748
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)
- ClinicalTrials.gov ID
- NCT01104805
- Acronym / sponsor ID
- CTN-0044 / NYSPI #6051
- Conditions
- Substance Abuse
- Keywords
- Drug Abuse, Substance Abuse, Substance Use Disorder, Addiction, Behavioral Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education System (TES) | Experimental | Behavioral: Therapeutic Education System (TES)Participants randomized to this arm will replace approximately 2 hours of Standard Treatment with the Therapeutic Education System (TES) (comprised of a web-based version of the Community Reinforcement Approach and contingency management). |
| Treatment-as-Usual (TAU) | Other | Behavioral: Treatment-as-Usual (TAU)Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Therapeutic Education System (TES)Also: Therapeutic Education System, TESParticipants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules. | Behavioural | Therapeutic Education System (TES) |
| Treatment-as-Usual (TAU)Also: Treatment as Usual, TAU, Standard TreatmentParticipants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling. | Behavioural | Treatment-as-Usual (TAU) |
Primary outcome
Reduced Substance Use and Improved Treatment Retention
Time frame: 12-week Treatment Phase
Compared to patients assigned to Treatment as Usual (TAU), patients assigned to modified TAU plus the Therapeutic Education System (Modified TAU + TES) will have: 1. reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and 2. better retention in treatment at their community-based treatment programs.
4 secondary outcomes
Effectiveness
Time frame: 12-week treatment phase, 3- and 6-months post treatment
Sustained outcome
Time frame: 3- and 6-months post treatment
Economic Analysis
Time frame: 12-week treatment phase, 3- and 6-months post treatment
Coping Skills
Time frame: 12-week treatment phase, 3- and 6-months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 34366201Luderer 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.
- Derived from this study: PubMed 26880594Murphy 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.
- Derived from this study: PubMed 25697725Cochran 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.
- Derived from this study: PubMed 25671593Mitchell 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.
- Derived from this study: PubMed 24708748Cochran 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.
- National Institute on Drug Abuse, Clinical Trials NetworkLink provided by the sponsor.
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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.
Edward V Nunes, MD principal investigator
NIDA Clinical Trials Network - Long Island Regional Node
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education System (TES) and Treatment-as-Usual (TAU) in people with Substance Abuse, run by New York State Psychiatric Institute at 10 sites 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 5 inclusion and 4 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduced Substance Use and Improved Treatment Retention (time frame: 12-week Treatment Phase). 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 NCT01104805, which also lists 5 linked publications.
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 11 Jul 2017.