---
title: Methadone Oxytocin Option
nct_id: NCT01728909
overall_status: COMPLETED
phase: EARLY_PHASE1
sponsor: University of California, San Francisco
study_type: INTERVENTIONAL
primary_condition: Substance Abuse
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01728909.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01728909"
ct_last_update_post_date: 2019-05-21
last_seen_at: "2026-05-12T06:36:28.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Methadone Oxytocin Option

**Official Title:** The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients

**NCT ID:** [NCT01728909](https://clinicaltrials.gov/study/NCT01728909)

## Key Facts

- **Status:** COMPLETED
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** University of California, San Francisco
- **Collaborators:** San Francisco Veterans Affairs Medical Center
- **Conditions:** Substance Abuse, Opioid Dependence, Methadone Treatment
- **Start Date:** 2012-05
- **Completion Date:** 2014-10
- **CT.gov Last Update:** 2019-05-21

## 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

- **Minimum age:** 18 Years
- **Sex:** MALE
- **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
```

## Arms

- **Oxytocin** (EXPERIMENTAL) — 40 IU Oxytocin
- **Saline Nasal Spray** (PLACEBO_COMPARATOR) — Placebo Comparator

## Interventions

- **Oxytocin** (DRUG) — 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
- **Saline Nasal Spray** (DRUG) — 40 IU of the saline nasal spray will be administered once at the beginning of the visit.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Craving Questionnaires** _(time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.)_

## Locations (1)

- San Francisco VA Medical Center, San Francisco, California, United States

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.san francisco va medical center|san francisco|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01728909.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01728909*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*