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Trial · Interventional

CompletedEarly phase 1Registry data

Methadone Oxytocin Option

Short name MOO

NCTNCT01728909 (opens ClinicalTrials.gov in a new tab)Other id11-07691
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Early phase 1
Enrollment
64 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
May 2012
Primary completion
Oct 2014
Completion
Oct 2014
First posted
20 Nov 2012 (estimated)
Last update posted
21 May 2019
Conditions
Substance Abuse · Opioid Dependence · Methadone Treatment

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph Early 1

    MOO

    NCT01728909

    May 2012 to Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • Saline Nasal SprayDrug

Arms2

  • Experimental

    Oxytocin

    40 IU Oxytocin

  • Placebo comparator

    Saline Nasal Spray

    Placebo Comparator

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Computerized Social Cognition Tasks

    Time frame · Participants will complete 2 days of the study. These 2 days will be at least a week apart.

    Registry description

    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(1)

  1. Craving Questionnaires

    Time frame · Participants will complete 2 days of the study. These 2 days will be at least a week apart.

    Registry description

    Participants are asked to rate their current symptoms and current craving levels and for different substances.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

5 results

The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study.

Woolley et al. 2016Psychopharmacologycited by 38

PMID 27137199PMC7452038DOI 10.1007/s00213-016-4308-8PUB-27137199

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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