Methadone Oxytocin Option (MOO)

University of California San Francisco (UCSF)

Status and phase

Completed

Early Phase 1

Conditions

Methadone Treatment

Substance Abuse

Opioid Dependence

Treatments

Drug: Oxytocin

Drug: Saline Nasal Spray

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT01728909

11-07691

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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