Methadone Oxytocin Option

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Substance Abuse Opioid Dependence Methadone Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin

40 IU Oxytocin

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Saline Nasal Spray

Placebo Comparator

Group Type PLACEBO_COMPARATOR

Saline Nasal Spray

Intervention Type DRUG

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Interventions

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Oxytocin

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Intervention Type DRUG

Saline Nasal Spray

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Intervention Type DRUG

Other Intervention Names

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Syntocinon Placebo

Eligibility Criteria

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Inclusion Criteria

* 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

-No diagnosis of mental disorder according to DSM-IV TR

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes