None listed
Conditions
Brief summary
Cannabis is the most widely used illicit drug and is associated with considerable health related morbidity. About 1 in 10 cannabis users become dependent on the drug leading to high-level of treatment seeking. There is increasing interest in the idea that severe cannabis dependence might be effectively treated by substituting smoked cannabis for a safer, more benign cannabinoid agonist medication. Recent laboratory studies suggest this approach holds promise as an effective therapy in dependent users. Our team has recently published the first ever-clinical trial of the cannabinoid agonist medication Sativex in alleviating cannabis withdrawal. This world first study demonstrated the safety and efficacy of Sativex relative to Placebo in an inpatient setting. This project proposed the first ever outpatient randomised controlled trial (RCT) to test the efficacy, safety and cost effectives of Sativex for treating cannabis dependence the community. Sativex will be given to severely cannabis dependant patients who have not previously responded to conventional treatment. Subjects (n=142) will be randomly allocated to a 12-week course of Sativex or placebo, with standard counselling and clinical reviews across both groups, and a 12-week follow up after the completion of maintenance dosing. This proposal presents an exciting innovation in the embryonic field of clinical research into the world’s most prevalent illicit drug. As well as examining the efficacy of this medication, the trial will address a range of issues important in any future translation of Sativex use into routine clinical practice. The development of an effective medication for treating cannabis dependence would have wide reaching clinical and public health benefits.
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. The spray container should be shaken before use and the spray should be directed at different sites inside the mouth changing the application site each time the product is used. A 2-5 second time frame between each spray administered should be allowed in order for the spray to be absorbed through the lining of the cheeks.
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. The spray container should be shaken before use and the spray should be directed at different sites inside the mouth changing the application site each time the product is used. A 2-5 second time frame between each spray administered should be allowed in order for the spray to be absorbed through the lining of the cheeks. Dosage form/strength: Medication is in 10 ml containers; maximum dose of individually titrated doses, up to 8 sprays (21.6 mg THC:20 mg CBD) delivered as buccal spray up to four times a day. Participants are in a 12 week outpatient treatment. Week 1: all participants will be advised the following doses. Day 1: up to 2 sprays 4 times a day, Day 2-3: can increase to 4 sprays, 4 times a day. Days 4-7: can increase up to 8 sprays, 4 times a day. Dosage for the first week will be dependent on a participant-to-participant bases and their levels of cannabis craving. Weeks 2-12: Doses during the maintenance phase will be based upon the dose determined by the doctor and participant at the end of week 1, and individually titrated up to a maximum of 8 sprays, 4 times a day. Adherence will be monitored by weekly clinical reviews with the research nurse. The nurse will weigh bottles to measure maximum prescribed dose and expect participants to return any empty bottle containers at each review.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(a) aged 18 to 65 years, (b) meet ICD-10 cannabis dependence criteria; (c) have previously attempted but not responded to treatment for cannabis use (operationalized as relapsed to regular cannabis use within 28 days of treatment cessation); and (d) willing and able to provide informed consent to study procedures (including not driving or operating machinery if Sativex is affecting their ability to perform these tasks, consistent with the Product Label).
Exclusion criteria
(a) Presence of another substance use disorder (alcohol, other illicit or prescription drug dependence), diagnosed by specialist clinical assessment, including urine drug screen (UDS); Patients taking disulfiram for the treatment of alcohol dependence should be excluded due to the possible interaction with the small amounts of alcohol in Sativex. However, patients with a past history of alcohol dependence who are now in remission should not necessarily be discriminated against from participating in the study. Rather, the study medical officer will explain the amount of alcohol in a typical sativex dose used in this study (usually less than 0.5gm alcohol per dose or 0.2 standard drink per day), and then discuss with the patient the relative relapse risks. Of course, many individuals with a past history of alcohol dependence and in remission do not strictly adhere to abstinence from alcohol, and many such individuals may consider the risks of participating as acceptable. Others may want to remain completely abstinent from alcohol and avoid even small amounts of alcohol associated with Sativex. Hence in summary, past alcohol dependence in remission is not an automatic exclusion criteria, but will be individualised with each participant. (b) severe medical (e.g. chronic pain, hepatic or cardiovascular disease) or psychiatric disorder (e.g. schizophrenia, recent drug-induced psychosis, severe affective disorder), assessed by the study medical officer; (c) pregnant or lactating women (urine beta-hCG); (d) concerns regarding safe storage of medication (e.g. unsuitable home environment or significant child protection concerns); (e) not available for follow-up (e.g. likely travel or imprisonment). (f) Mandated by court to attend cannabis treatment. (g) History of epilepsy or recurrent seizures. (h) Renal impairment These criteria aim to exclude individuals with concurrent conditions that jeopardise safety or confound data interpretation.
Outcome results
None listed