Centre for Alcohol and Drug Research, Bartholins Allé 10, 8000, Aarhus C, Denmark.
BMC Psychiatry. 2021 Apr 7;21(1):183. doi: 10.1186/s12888-021-03182-6.
Substance use disorders show a high comorbidity with externalizing behavior difficulties, creating treatment challenges, including difficulties with compliance, a high risk of conflict, and a high rate of offending post-treatment. Compared with people with other substance use disorders those with opioid use disorders have the highest risk of criminal activity, but studies on the evidence base for psychosocial treatment in opioid agonist treatment (OAT) are scarce. The Impulsive Lifestyle Counselling (ILC) program may be associated with better retention and outcomes among difficult-to-treat patients with this comorbidity.
The study is a multicenter, randomized, controlled, superiority clinical trial. Participants will be a total of 137 hard-to-treat individuals enrolled in opioid agonist treatment (OAT). Participants will be randomized to either a standard treatment (14 sessions of individual manual-based cognitive behavioral therapy and motivational interviewing (MOVE-I)) or six sessions of ILC followed by nine sessions of MOVE-I. All participants will receive personalized text reminders prior to each session and vouchers for attendance, as well as medication as needed. The primary outcome is retention in treatment. Secondary measures include severity of drug use and days of criminal offending for profit three and nine months post-randomization. A secondary aim is, through a case-control study, to investigate whether participants in the trial differ from patients receiving treatment as usual in municipalities where ILC and MOVE-I have not been implemented in OAT. This will be done by comparing number of offences leading to conviction 12 months post-randomization recorded in the national criminal justice register and number of emergency room contacts 12 months post-randomization recorded in the national hospital register.
This is the first randomized, controlled clinical trial in OAT to test the effectiveness of ILC against a standardized comparison with structural elements to increase the likelihood of exposure to the elements of treatment. Results obtained from this study may have important clinical, social, and economic implications for publicly funded treatment of opioid use disorder.
ISRCTN, ISRCTN19554367 , registered on 04/09/2020.
物质使用障碍与外在行为困难高度共病，这给治疗带来了挑战，包括遵医嘱困难、冲突风险高、治疗后再犯罪率高。与其他物质使用障碍患者相比，阿片类物质使用障碍患者的犯罪活动风险最高，但在阿片类激动剂治疗（OAT）中，针对心理社会治疗的证据基础研究却很少。冲动生活方式咨询（ILC）方案可能与难以治疗的共病患者的更好保留和结果相关。
该研究是一项多中心、随机、对照、优势临床试验。共有 137 名难以治疗的阿片类激动剂治疗（OAT）患者参加。参与者将随机分为标准治疗组（14 次个体基于手册的认知行为疗法和动机访谈（MOVE-I））或 6 次 ILC 加 9 次 MOVE-I。所有参与者将在每次治疗前收到个性化的文本提醒和出席代金券，并根据需要提供药物治疗。主要结局是治疗保留率。次要测量指标包括随机分组后 3 个月和 9 个月时药物使用的严重程度和为盈利而犯罪的天数。次要目标是通过病例对照研究，调查在没有实施 ILC 和 MOVE-I 的市政当局，试验参与者与接受常规治疗的患者有何不同。这将通过比较 12 个月时随机分组后记录在国家刑事司法登记处的定罪犯罪数量和 12 个月时随机分组后记录在国家医院登记处的急诊室接触次数来完成。
这是 OAT 中首次针对 ILC 的有效性进行的随机对照临床试验，与结构要素进行了标准化比较，以增加接触治疗要素的可能性。这项研究的结果可能对公共资助的阿片类物质使用障碍治疗具有重要的临床、社会和经济意义。
ISRCTN，ISRCTN84533103，于 2020 年 9 月 4 日注册。
