ACTRN12616000103460已完成2 期
A randomised control trial of cannabinoid replacement therapy (Sativex - registered trademark) for the management of treatment-resistant cannabis dependent patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •(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).
排除标准
- •(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.
研究者
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