Methadone Oxytocin Option (MOO)
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.
Drug: Saline Nasal Spray
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients Receiving Methadone Treatment|
- Computerized Social Cognition Tasks [ Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart. ] [ Designated as safety issue: No ]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.
- Craving Questionnaires [ Time Frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart. ] [ Designated as safety issue: No ]Participants are asked to rate their current symptoms and current craving levels and for different substances.
|Study Start Date:||May 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
40 IU Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Name: Syntocinon
Placebo Comparator: Saline Nasal Spray
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Name: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728909
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Joshua Woolley, MD, PhD||University of California San Francisco, San Francisco Veterans Affairs Medical Center|