Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

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.

Conditions

• Drug Dependence

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

Intranasal oxytocin given in the context of cognitive behavioral therapy

DRUG

Intranasal Oxytocin

Intranasal oxytocin given in the context of cognitive behavioral therapy

DRUG

Placebo

Placebo given in the context of cognitive behavioral therapy

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  lead NIH

Principal Investigators

• Mary R Lee, M.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2013-04-30

Completion

2013-04-30

Countries

• United States

Study Locations