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NCT00975416 · ClinicalTrials.gov registry record · Phase 4
Oxytocin and Cognitive Behavioral Therapy in Drug Dependence
A Phase 4 study, sponsored by National Institute on Drug Abuse (NIDA).
- Terminated
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
NCT00975416 is a Phase 4 study that was terminated before completion, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 63 participants.
The verdict
NCT00975416, a Phase 4 study, was terminated before completion, sponsored by National Institute on Drug Abuse (NIDA).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
Study Summary
Background: \- The therapeutic alliance between therapist and patient may contribute to favorable outcomes in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in other people and may reduce stress and improve comfort in social situations by decreasing the sensation of social anxiety. Researchers are interested in determining if oxytocin can improve the outcomes of therapy for drug dependence by strengthening perceived levels of trust between therapist and patient. Objectives: \- To determine whether oxytocin enhances the therapeutic alliance and treatment retention for CBT for drug use. Eligibility: \- Individuals between 18 and 65 years of age who are healthy volunteers with no history of drug abuse, participants in outpatient or inpatient treatment programs for cocaine use, methadone-dependent participants in a treatment program, or non-treatment-seeking cocaine users. Design: * Participants in each treatment arm who comply with the study requirements will be randomly assigned to receive one dose of oxytocin or placebo approximately 1 hour before each weekly CBT session. * The outpatient treatment intervention will be 12 weeks of weekly individual CBT. The inpatient treatment intervention will be 6 weeks of twice-weekly individual CBT sessions. Sessions will be audiotaped. Participants and counselors will be told that the sessions are to be taped. * During treatment, participants will provide urine and breath samples under staff observation. Participants will also complete questionnaires about mood and mental health, provide other samples as required, and participate in computerized psychological testing as directed by researchers.
Interventions
- DRUG Placebo
- BEHAVIORAL Cognitive Behavioral Therapy
- DRUG Intranasal Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-11 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00975416
The ClinicalTrials.gov registry entry for NCT00975416 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 63 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 3 interventions - of which Placebo is the first listed.
NCT00975416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00975416 about?
NCT00975416 is a clinical study titled "Oxytocin and Cognitive Behavioral Therapy in Drug Dependence". Background: \- The therapeutic alliance between therapist and patient may contribute to favorable outcomes in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug dependence. Oxytocin, a hormone and neurotransmitter, has been shown to increase trust in other people and ...
What is the current status of trial NCT00975416?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2008-11. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00975416?
The interventions under investigation include: Placebo (DRUG), Cognitive Behavioral Therapy (BEHAVIORAL), Intranasal Oxytocin (DRUG).
Who is sponsoring clinical trial NCT00975416?
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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