Methadone Oxytocin Option

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: San Francisco Veterans Affairs Medical Center
• Treatments: Oxytocin

Criteria

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