Therapeutic Alliance
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Inpatient Cocaine Oxytocin | 220.43 | 20.55 |
| Inpatient Cocaine Placebo | 223.13 | 41.81 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataThis trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Placebo comparator
Methadone
Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients
Placebo comparator
Outpatient Cocaine
Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients
Placebo comparator
Inpatient Cocaine
Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients
Outcomes the sponsor listed as primary.
Therapeutic Alliance
Time frame · Post 12 weeks treatment with cognitive behavioral therapy
Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance). Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Inpatient Cocaine Oxytocin | 220.43 | 20.55 |
| Inpatient Cocaine Placebo | 223.13 | 41.81 |
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| MethadoneIntranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy | – | 0 / 0 | 0 / 0 |
| Outpatient CocaineIntranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy | – | 0 / 0 | 0 / 0 |
| Inpatient CocaineIntranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy | – | 0 / 28 | 0 / 28 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Review · 2004
Amico et al. 2004Journal of neuroendocrinologycited by 220
PMID 15089969DOI 10.1111/j.0953-8194.2004.01161.xPUB-15089969
Indexing hint: Case report · 1994
Anderson-Hunt et al. 1994BMJ (Clinical research ed.)cited by 31
PMID 7950665PMC2541165DOI 10.1136/bmj.309.6959.929PUB-07950665
Who could join, as posted.
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