Double blind, randomised, placebo controlled trial of Sativex for the management of cannabis withdrawal

Phase 2

• Conditions: Cannabis withdrawal; Public Health - Health service research; Mental Health - Addiction

• Registration Number: ACTRN12611000398909
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Between 18-65 years of age (Both males and females)
2. Regular recent cannabis use (average of 5 times per week – self report)
3. Meet DSM-IV-TR 'Registered Trademark' criteria for cannabis dependence
4. Has made unsuccessful quit attempts in the past
5. Desire to give up cannabis
6. Prepared to enter a hospital ward for 9 days

If NO to any (1 - 6) client is not eligible for SATIVEX trial phone screen, provide usual referral/treatment advice.

Exclusion Criteria

1. More than twice weekly use of an illicit drug in the last 30 days (other than cannabis)
2. Dependence on a substance other than cannabis and tobacco
3. Pregnant or breastfeeding
4. Female of child bearing potential NOT using contraception
5. Evidence of severe medical impairment (e.g. chronic pain, severe hepatic impairment or cardiovascular disease)
6. Evidence of severe cognitive or psychiatric impairment (e.g. bipolar, schizophrenia, suicidal ideation)
7. Current (within past month) prescription for antipsychotic or mood stabilising medications
8. Currently prescribed warfarin
9. Allergy to cannabinoids, propylene glycol, ethanol or peppermint oil
10. Not English literate
11. Specialist substance use treatment in the last 30 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported measures of cannabis withdrawal using the Cannabis Withdrawal Scale (a modified version of the MWC (Budney et al., 1999)).[Four times a day for 9 days (6am, 11 am, 6pm and 10pm)];Treatment completion, defined as completing 9 days of inpatient treatment under protocol conditions (categorical yes/no); and number of days of inpatient treatment completed (range: 0-9).[Quantified once on day of patient discharge from hospital];Adverse events during the inpatient treatment period using a tailor made Adverse Events Checklist and administered by clinician/nurse/medical officer. Adverse events may include any of the following: Dizziness, Dry mouth, Tachycardia, Stomache ache, Slowed motor skills, slowed reaction time, anxiety, dysphoria, paranoia, oro-mucosal ulceration. Adverse events will be rated on a 0 - 3 scale, 0 being None, 1 being Mild, 2 being Moderate, 3 being Severe.[Once daily for the 9 days of inpatient stay]