Methadone Oxytocin Option

Early Phase 1CompletedNCT01728909

University of California, San Francisco64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Substance Abuse Opioid Dependence Methadone Treatment

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.

Secondary Outcomes

Craving Questionnaires

Participants are asked to rate their current symptoms and current craving levels and for different substances.