Methadone Oxytocin Option

Substance Abuse Clinical Trial

— MOO  

Official title:

The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728909
• Other study ID #: 11-07691
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT.

Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo.

Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo.

Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for patients:

• Primary diagnosis of opioid dependence according to DSM-IV TR

• Opioid of choice be either heroin or oral opioid analgesics

• Currently be on stable dose of methadone with no dose change in the last 14 days

Inclusion Criteria for healthy volunteers

-No diagnosis of mental disorder according to DSM-IV TR

Exclusion Criteria for patients and healthy volunteers:

• Epilepsy

• Current illicit drug use (within the past one month)

• Current sever depression with suicidal thoughts and/or actions

• Addiction to alcohol or drugs other than opiates, caffeine, or nicotine

• Psychotic illness

• Bipolar disorder

• Brain trauma

• Severe Neuropsychological disorder

• Kidney Disease (i.e., kidney stones, recurrent bladder infections, or known kidney failure)

• Sensitivity to preservatives (in particular E216, E218, and chlorobutanol hemihydrate)

• Nasal obstruction, discharge, or bleeding

• Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension)

• Habitually drink large volumes of water

Related Conditions & MeSH terms

• Methadone Treatment
• Opioid Dependence
• Opioid-Related Disorders
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
• Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computerized Social Cognition Tasks	Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.	Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Secondary	Craving Questionnaires	Participants are asked to rate their current symptoms and current craving levels and for different substances.	Participants will complete 2 days of the study. These 2 days will be at least a week apart.