Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

NCT00975416 | Terminated Phase 4 Results

• 2 other identifiers: 99990843208-DA-N432
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Drug Dependence; Cognitive Behavior; Oxytocin; Cocaine; Heroin; fMRI

Outcome Measures

Primary Outcomes (1)

• Therapeutic Alliance

  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).

  Post 12 weeks treatment with cognitive behavioral therapy

Other Outcomes (1)

• Drug Craving

  Post-treatment

Study Arms (3)

Methadone

PLACEBO COMPARATOR

Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients

Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo

Outpatient Cocaine

PLACEBO COMPARATOR

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients

Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo

Inpatient Cocaine

PLACEBO COMPARATOR

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients

Behavioral: Cognitive Behavioral Therapy; Drug: Intranasal Oxytocin; Drug: Placebo

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Intranasal oxytocin given in the context of cognitive behavioral therapy

Inpatient Cocaine; Methadone; Outpatient Cocaine

Intranasal Oxytocin DRUG

Intranasal oxytocin given in the context of cognitive behavioral therapy

Inpatient Cocaine; Methadone; Outpatient Cocaine

Placebo DRUG

Placebo given in the context of cognitive behavioral therapy

Inpatient Cocaine; Methadone; Outpatient Cocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants must:
• Be between age 18 and 65.
• Methadone arm only: opiate dependence for the past year determined by clinical exam, opiate-positive urine during screening and diagnosis confirmed by SCID.
• Cocaine outpatient arm: cocaine dependence determined by clinical exam, cocaine-positive urine during screening and diagnosis confirmed by SCID.
• Cocaine inpatient arm: Cocaine dependence determined by clinical exam during screening and diagnosis confirmed by SCID.
• Control participants: cocaine dependent and non-drug using, will be recruited to provide appropriate matches for subjects in the two treatment arms with respect to the following characteristics: age, gender, IQ, socioeconomic factors, and years of education.
• For participation in the scanning portion of the study, participants must also:
• Be between the ages of 18-55. Justification: Many of the cognitive processes under study change with age. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age. Individuals over 55 will therefore be excluded. Assessment tool(s): driver s license, birth certificate, or other government-issued form of identification.

You may not qualify if:

• Be right-handed. Justification: Many of the brain functions to be assessed in this protocol have shown some evidence of being lateralized in the brain. In order to reduce variability in the data, participants must be right-handed. Assessment tool(s): Edinburgh Handedness Inventory.
• Participants will be excluded if they have evidence of:
• Schizophrenia or any other DSM-IV psychotic disorder; history of bipolar disorder; current major depressive disorder.
• Current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by DSM-IV criteria), except for inpatient cocaine arm.
• Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
• Renal insufficiency with serum creatinine greater than 1.7.
• Medical illness that in the view of the investigators would compromise participation in research such as: a history of syncope, family history of sudden death, electrolyte imbalance, bradycardia, arrhythmias, marked sustained high BP with SBP \> 160 and or DBP \> 100 on more than two readings without 3rd reading being below these parameters and not stabilized on antihypertension medications before the starting the study, congestive heart failure, history or finding on screening EKG of significant abnormality such as prolonged QTc (\> 450ms) , or AIDS or HIV positive with T cell count less than or equal to 200.
• Urologic conditions that would inhibit urine collection.
• Untreated Endocrine disorders.
• Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of child-bearing age who are sexually active are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include:
• hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones),
• surgical sterility (tubal ligation or hysterectomy)
• IUD
• Diaphragm with spermicide
• Condom with spermicide

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Aharon I, Etcoff N, Ariely D, Chabris CF, O'Connor E, Breiter HC. Beautiful faces have variable reward value: fMRI and behavioral evidence. Neuron. 2001 Nov 8;32(3):537-51. doi: 10.1016/s0896-6273(01)00491-3.

  PMID: 11709163 BACKGROUND

• Amico JA, Mantella RC, Vollmer RR, Li X. Anxiety and stress responses in female oxytocin deficient mice. J Neuroendocrinol. 2004 Apr;16(4):319-24. doi: 10.1111/j.0953-8194.2004.01161.x.

  PMID: 15089969 BACKGROUND

• Anderson-Hunt M, Dennerstein L. Increased female sexual response after oxytocin. BMJ. 1994 Oct 8;309(6959):929. doi: 10.1136/bmj.309.6959.929. No abstract available.

  PMID: 7950665 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

1 participant committed suicide outside of that occurred outside of adverse event time frame. There were 12 occurrences of computer malfunction during the study. This did not effect data collection for primary outcome measures.

Results Point of Contact

• Title: Mary R. Lee, M.D.
• Organization: National Institute on Drug Abuse

leemary@mail.nih.gov

301-825-0545

Study Officials

• Mary R Lee, M.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (1)