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NCT01532934 · ClinicalTrials.gov registry record · Phase 2
The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT01532934: Completed Phase 2 study, sponsored by University of Rochester.
NCT01532934 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532934, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are needed. Forensic populations are often viewed with considerable therapeutic pessimism. However, offenders exhibit heterogeneity in personality traits, and the assessment of individual differences among offenders may provide valuable information that guides the use of psychotherapeutic interventions. Among offenders, psychopathy has emerged as an important personality construct for the understanding of violence and criminal recidivism. Moreover, core traits of psychopathy such as lack of empathy, deceitfulness, and lack of remorse may have negative implications for the efficacy of psychosocial interventions. A foundational premise of the present work is that understanding the moderating role of psychopathic traits on substance use treatment outcomes among offenders is essential to determining what works, and for whom. The current proposal is a Phase II randomized clinical trial that aims to examine the impact of psychopathic traits on the efficacy of a brief substance use intervention for offenders in a jail diversion program. Hypotheses that will be examined include: 1) that a Motivational Interviewing (MI) - based treatment will reduce substance use and related consequences relative to a Standard Care only condition, 2) that the reduction in substance use in the intervention group will mediate a reduction in later criminal recidivism relative to the Standard Care condition, and 3) that core psychopathic traits will moderate the efficacy of the intervention such that individuals with lower levels of these traits will derive greater benefits with regard to decreased substance use, decreased drug use consequences, and decreased criminal recidivism at a one-year follow-up.
Primary Outcome
Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.
Interventions
- OTHER standard care
- BEHAVIORAL motivational enhancement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01532934 record still lists
NCT01532934 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which standard care is the first listed.
NCT01532934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532934 about?
NCT01532934 is a clinical study titled "The Impact of Psychopathic Traits on the Efficacy of a Substance Use Intervention". Substance use among criminal offenders constitutes a major public health problem and is tied to negative consequences for offenders, their families, and their communities. One of the direst of these consequences is repeated incarceration; thus, interventions that reduce criminal recidivism are neede...
What is the current status of trial NCT01532934?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2009-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01532934?
The interventions under investigation include: standard care (OTHER), motivational enhancement therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01532934?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532934's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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