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NCT04007666 · ClinicalTrials.gov registry record · NA
Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 148
- Enrollment target
NCT04007666: Completed NA study, sponsored by University of Arkansas.
NCT04007666 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04007666, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
Study Summary
The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that address the needs of the criminal justice system. The proposed research will be conducted as part of Dr. Zielinski's Mentored Patient-Oriented Research Career Development Award (K23), which aims to: 1) advance knowledge on implementation of a gold-standard psychotherapy for trauma, Cognitive Processing Therapy (CPT), in the prison setting and 2) examine whether prison-delivered CPT reduces drug use, psychiatric symptoms, and recidivism compared to a control condition (a coping-focused therapy). These foci have been selected because severe trauma exposure, substance use, and justice-involvement overwhelmingly co-occur in prison populations. The three specific aims in this research are: 1) Use formative evaluation to identify factors that may influence implementation and uptake of CPT in prisons, 2) Adapt CPT for incarcerated drug users and develop a facilitation-based implementation guide to support its uptake, and 3) conduct a participant-randomized Hybrid II trial to assess effectiveness and implementation outcomes of CPT with incarcerated drug users. Participants will include people who have been incarcerated (pre- and post-release from incarceration) and prison stakeholders who will be purposively sampled based on their role in implementation of CPT and other programs. Anticipated enrollment across all three Aims is 244 adult men and women.
Primary Outcome
Drug use will be examined as both binary responses (abstinence vs. any use) and frequency counts (number of days of use). These variables will be derived from information gained via Timeline Follow-Back Interview.
Interventions
- BEHAVIORAL Cognitive Processing Therapy
- BEHAVIORAL Control Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2019-08-16 |
| Est. Completion | 2025-05-08 |
| Phase | NA |
What the finished NCT04007666 record still lists
NCT04007666 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Processing Therapy is the first listed.
NCT04007666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04007666 about?
NCT04007666 is a clinical study titled "Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users". The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that ...
What is the current status of trial NCT04007666?
This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2019-08-16. Estimated completion is 2025-05-08.
What interventions are being tested in trial NCT04007666?
The interventions under investigation include: Cognitive Processing Therapy (BEHAVIORAL), Control Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT04007666?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04007666's enrollment target sits among peer trials
148 702nd of 2000 higher than 1,298 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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