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NCT01177982 · ClinicalTrials.gov registry record · Phase 2
Reinforcement-Based Treatment for Pregnant Drug Abusers
A Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
NCT01177982 is a Phase 2 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 220 participants.
The verdict
NCT01177982, a Phase 2 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
Study Summary
Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for substance-using pregnant patients. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion, and maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of length of hospitalization, and birth outcomes. Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.
Interventions
- BEHAVIORAL Usual RBT (t-RBT)
- BEHAVIORAL Reduced RBT (r-RBT)
- BEHAVIORAL Abbreviated RBT (a-RBT)
- BEHAVIORAL Enhanced RBT (e-RBT)
- BEHAVIORAL Early compliant t-RBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01177982
The ClinicalTrials.gov registry entry for NCT01177982 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Usual RBT (t-RBT) is the first listed.
NCT01177982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01177982 about?
NCT01177982 is a clinical study titled "Reinforcement-Based Treatment for Pregnant Drug Abusers". Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for subst...
What is the current status of trial NCT01177982?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2009-07. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01177982?
The interventions under investigation include: Usual RBT (t-RBT) (BEHAVIORAL), Reduced RBT (r-RBT) (BEHAVIORAL), Abbreviated RBT (a-RBT) (BEHAVIORAL), Enhanced RBT (e-RBT) (BEHAVIORAL), Early compliant t-RBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT01177982?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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