None listed
Conditions
Brief summary
The primary objective of the study is to examine the safety and efficacy of SATIVEX 'Registered Trademark (R)' in the inpatient management of cannabis withdrawal, in a double blinded randomised trial compared to placebo. Specifically, the study will compare withdrawal severity, detoxification completion and adverse events between the two conditions in an intention-to-treat analysis. Secondary objectives include 1-month post-withdrawal outcomes (including cannabis and other drug use and psychosocial outcomes), and to assess the relationship between the number, severity and duration of cannabis withdrawal symptoms and rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at one month follow-up. The study will also explore the cognitive impact of withdrawing from cannabis, as well as the impact of SATIVEX on cognitive functioning, with an aim to assessing the real world safety profile of the drug ahead of larger outpatient studies. The study will also explore the pharmacokinetics and metabolites associated with SATIVEX (R) administration to develop a protocol for differentiating between SATIVEX(R) and illicit cannabis in blood or urine among those entering cannabis withdrawal treatment. This pharmacokinetic assay will prove useful for future large scale outpatient trials should the current trial prove successful. A final exploratory objective of the study is to determine whether there is evidence of an interaction with the efficacy of SATIVEX(R) and patient characteristics on admission (including demographics and cannabis and other use and psychosocial factors such as treatment expectancy) on reported severity of cannabis withdrawal and subsequent post-withdrawal outcomes (cannabis use, psychosocial outcomes, sleep disturbances and cannabis-related problems) to be fully tested in a larger community study.
Interventions
Investigational drug: Sativex (1 spray: 2.7 mg THC and 2.5 mg CBD) in an alcohol and peppermint oil liquid administered as an oromucosal spray onto the inside of the mouth (but not intended to be swallowed and digested through the stomach - so some time (1 minute) should be taken after each single spray is administered to ensure absorption, before the next spray is administered). The patient cannot choose when they receive their 8 spray dose, they must have them all at the 6 hourly interval.
Do
Investigational drug: Sativex (1 spray: 2.7 mg THC and 2.5 mg CBD) in an alcohol and peppermint oil liquid administered as an oromucosal spray onto the inside of the mouth (but not intended to be swallowed and digested through the stomach - so some time (1 minute) should be taken after each single spray is administered to ensure absorption, before the next spray is administered). The patient cannot choose when they receive their 8 spray dose, they must have them all at the 6 hourly interval. Dosage form/strength: maximum 800 uL every six hours (X8 sprays every six hours). Participants may not take partial doses (i.e. 6 sprays) but they can ask to miss up to two of the 6 hourly dose in a day. Patients are in hospital for 8 nights, discharging on day 9.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed