Substance Abuse, Opioid Dependence, Methadone Treatment
Conditions
Keywords
Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors
Brief 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.
Interventions
DRUGOxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Sponsors
San Francisco Veterans Affairs Medical Center
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Computerized Social Cognition Tasks | Participants will complete 2 days of the study. These 2 days will be at least a week apart. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Craving Questionnaires | Participants will complete 2 days of the study. These 2 days will be at least a week apart. | Participants are asked to rate their current symptoms and current craving levels and for different substances. |
Countries
United States
Outcome results
None listed