Methadone Oxytocin Option

Early Phase 1

Completed

• Conditions: Methadone Treatment; Substance Abuse; Opioid Dependence
• Interventions: Drug: Saline Nasal Spray; Drug: Oxytocin

• Registration Number: NCT01728909
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline Nasal Spray	Saline Nasal Spray	Placebo Comparator
Oxytocin	Oxytocin	40 IU Oxytocin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States