Intranasal oxytocin for the treatment of cannabis and alcohol dependence

Phase 3

Recruiting

• Conditions: Cannabis and alcohol dependence; Mental Health - Addiction; Mental Health - Depression

• Registration Number: ACTRN12610000742077
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Diagnostic and Statistical Manual for Mental Disorders-IV diagnostic criteria for cannabis and alcohol dependence.

Exclusion Criteria

Epilepsy
Severe depression with suicidal thoughts and/ or actions
Drug addiction (other than nicotine, cannabis, or alcohol)
Currently take medication and you are not stable on this medication (i.e., have been taking the medication for less than 4 weeks)
Are currently receiving psychological or pharmacological treatment for substance use problems
Kidney Disease- (i.e., kidney stones, recurrent bladder infections, or known kidney failure).
Severe liver disease (e.g., decompensated hepatic failure)
Sensitivity to preservatives (in particular E 216, E 218 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
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic criteria for cannabis and alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders IV text revision.<br><br>Time-line follow back for assessing cannabis and alcohol consumption[Induction and 4 weeks post drug treatment.];Reduction in cannabis and associated alcohol craving and withdrawal using the following measures: <br><br>Cannabis Problems Questionnaire<br>Cannabis Use Disorders Identification Test - revised<br>Severity of dependence scale - cannabis<br>Marijuana Withdrawal Scale<br>Depression Anxiety Stress Scale - 21<br>K-10 depression scale<br>Social Interaction Anxiety Scale<br>Pittsburgh Sleep Quality Index<br>World Health Organisation Disability Assessment Schedule - II<br>Severity of Dependence Scale - alcohol<br>Alcohol Use Disorders Identification Test<br>Obsessive Compulsive Drinking Scale[Baseline, 4-week, 8-week.]

Secondary Outcome Measures

Name	Time	Method
Reduction in neurocognitive and psychosocial impairment using the Reading the Mind in the Eyes task, Eye-gaze to social cues task using TobiiStudio eye tracking technology, and the Movie Stills Task. These tasks are conducted using a computer and eye gaze technology.[Baseline, 4-week, 8-week.];We will also be assessing changes in biological functioning that include body mass index, blood plasma cortisol, vasopressin, and oxytocin using Enzyme Immunoassay and assessing heart rate and blood pressure.[Baseline, 4-week, 8-week.]