RecruitingPhase 3ACTRN12610000742077

Intranasal oxytocin for the treatment of cannabis and alcohol dependence

The effect of intranasal oxytocin on cannabis and associated alcohol cravings and withdrawal in patients diagnosed with cannabis and alcohol dependence


Sponsor

University of Sydney

Enrollment

80 participants

Start Date

Apr 29, 2010

Study Type

Interventional

Conditions

Summary

This double-blind, randomised, placebo controlled trial will examine the safety and efficacy of intranasal oxytocin for the treatment of cannabis and alcohol dependence. It is hypothesised that participants randomised to the oxytocin condition, compared to participants randomised to the placebo condition will have a higher rate of treatment completion, experience reduced number, severity, and duration of cannabis and alcohol withdrawal symptoms and will report fewer days of cannabis and alcohol use at one month follow-up.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

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

Exclusion Criteria12

  • 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

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Interventions

40 international units of oxytocin intranasally twice per day for 4 weeks.

40 international units of oxytocin intranasally twice per day for 4 weeks.


Locations(1)

Australia

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ACTRN12610000742077