Methadone Oxytocin Option (MOO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01728909|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse Opioid Dependence Methadone Treatment||Drug: Oxytocin Drug: Saline Nasal Spray||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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
- Computerized Social Cognition Tasks [ Time Frame: 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.
- Craving Questionnaires [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|