Clinical trial NCT01728909: Methadone Oxytocin Option
Official title: The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Substance Abuse
Opioid Dependence
Methadone Treatment
Keywords: Oxytocin
Syntocinon
Social Cognition
Social Approach Behaviors
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2012-11-20
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Computerized Social Cognition Tasks
timeFrame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Secondary outcomes:
measure: Craving Questionnaires
timeFrame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: University of California San Francisco, San Francisco Veterans Affairs Medical Center
name: Joshua Woolley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woolley JD, Arcuni PA, Stauffer CS, Fulford D, Carson DS, Batki S, Vinogradov S. The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study. Psychopharmacology (Berl). 2016 Jul;233(13):2571-80. doi: 10.1007/s00213-016-4308-8. Epub 2016 May 3.