Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
EBioMedicine. 2018 Mar;29:177-189. doi: 10.1016/j.ebiom.2018.01.039. Epub 2018 Feb 2.
Cocaine use disorder (CUD) is a debilitating condition with no NICE-recommended medication or specific psychosocial interventions. In the United Kingdom (UK), general counselling (treatment-as-usual; TAU) is widely delivered, but has limited effectiveness. We tested the feasibility, safety and preliminary efficacy of a novel, adjunctive psychosocial intervention for CUD, called 'memory-focused cognitive therapy' (MFCT).
We did a two-arm, external pilot randomised controlled trial at a specialist community National Health Service addictions clinic in London, UK. 30 adults (≥18years), voluntarily seeking treatment for CUD (enrolled ≥14days; all with moderate-to-severe DSM5 CUD), were individually randomised (1:1) to a control group (ongoing TAU; 3×90min CUD cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; and 3×30min research follow-ups); or to an intervention group (ongoing TAU; 3×90min cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; 5×120min, one-to-one, MFCT sessions [in 1week]; and 3×60min research follow-ups and MFCT-relapse prevention). The primary outcome was the total percentage score on the frequency version of the Craving Experiences Questionnaire (CEQ-F) at 1-month follow-up after the intensive intervention week (clinical endpoint; recall period past 2weeks; higher score indicating greater craving). Secondary outcomes at the 1-month follow-up were percentage days abstinent (PDA) from cocaine, and longest period (days) of continuous abstinence (LPA) in the prior 28days. Outcomes were analysed as an unadjusted group mean difference (with Hedge's g effect size [ES]) and a 95% Confidence Interval [CI] for the primary outcome and a 90% CI for the secondary outcomes. Exploratory, multivariable linear (primary outcome) and Poisson regression models (secondary outcomes), with sex, age, months of regular cocaine use, baseline outcome score, and group estimated the effectiveness of the intervention. The trial is registered with the ISCRTN (ISRCTN16462783).
Between July 15, 2015, and November 27, 2016, 58 patients were assessed for eligibility and 30 participants were randomised (14 to the control group and 16 to the intervention). With outcome data collected for all participants at the endpoint, the intervention group mean CEQ-F score (14·77; SD 21·47) was lower than the control group mean (51·75; SD 22·72); ES -1·62; 95% CI -2·45 to -0·80. MFCT was associated with more cocaine abstinence in the intervention group (PDA 85·94; SD 18·96) than the control group (PDA 54·59; SD 30·29); ES 1·19; 90% CI 0·54 to 1·84. There was also greater maximum abstinence in the intervention group (LPA 15·69; SD 10·10) than the control group (6·00; SD 7·36); ES 1·06; 90% CI 0·41 to 1·70. Exploratory, confounder-adjusted regression models for this preliminary effect supported the treatment association for reduced craving experiences (CEQ-F Coef. -28·25; 95% CI -45·15 to -11·35); more abstinence (PDA Incidence Rate Ratio [IRR] 1·56; 95% CI 1·31 to 1·88); and greater maximum abstinence (LPA IRR 2·56; 95% CI 1·96 to 3·35), although relative weak unmeasured confounding could overturn these model-adjusted exposure-outcome associations. There were four serious adverse events (among three participants). None were judged related to study procedures or interventions.
In this first external pilot randomised controlled trial of MFCT for CUD, we have shown that the intervention and control procedures and acceptable feasible and safe, and report preliminary evidence that MFCT is associated with reduced craving and increased abstinence. These findings support progression to a substantive trial.
UK National Institute for Health Research, Biomedical Research Centre.
可卡因使用障碍（CUD）是一种使人衰弱的疾病，英国国家卫生与临床优化研究所（NICE）没有推荐药物或特定的心理社会干预措施。在英国，一般咨询（常规治疗；TAU）被广泛提供，但效果有限。我们测试了一种新的、辅助性的可卡因使用障碍心理社会干预措施，称为“记忆导向认知疗法”（MFCT），其可行性、安全性和初步疗效。
我们在英国伦敦的一家专门的社区国家卫生服务成瘾诊所进行了一项为期两周的、外部试点的、随机对照试验。30 名成年人（≥18 岁）自愿接受可卡因使用障碍治疗（入组≥14 天；所有患者均有中度至重度 DSM5 可卡因使用障碍），他们被单独随机分为对照组（常规治疗；3×90 分钟可卡因认知概念化评估；2×30 分钟可卡因相关线索诱导程序；和 3×30 分钟研究随访）或干预组（常规治疗；3×90 分钟认知概念化评估；2×30 分钟可卡因相关线索诱导程序；5×120 分钟、一对一的 MFCT 疗程（1 周内）；和 3×60 分钟研究随访和 MFCT 复发预防）。主要结局是强化干预周后 1 个月随访时的渴望体验问卷（CEQ-F）的总频率版本的百分比评分（临床终点；回忆期过去 2 周；得分越高表示渴望程度越高）。次要结局是 1 个月随访时的可卡因戒断天数百分比（PDA）和过去 28 天内最长的连续戒断天数（LPA）。结果作为未调整的组平均差异（用 Hedge's g 效应大小[ES]和 95%置信区间[CI]表示）和次要结局的 90%置信区间进行分析。探索性、多变量线性（主要结局）和泊松回归模型（次要结局），考虑了性别、年龄、可卡因使用的月数、基线结局评分和组，估计了干预的效果。该试验在 ISCRTN（ISRCTN81345402）注册。
2015 年 7 月 15 日至 2016 年 11 月 27 日，对 58 名患者进行了资格评估，30 名参与者被随机分配（对照组 14 名，干预组 16 名）。所有参与者均在终点处收集结局数据，干预组的 CEQ-F 评分（14.77；SD 21.47）低于对照组（51.75；SD 22.72）；ES-1.62；95%CI-2.45 至-0.80。MFCT 与干预组（PDA 85.94；SD 18.96）相比，对照组（PDA 54.59；SD 30.29）的可卡因戒断率更高；ES 1.19；90%CI 0.54 至 1.84。干预组的最大戒断时间也更长（LPA 15.69；SD 10.10），而对照组（LPA 6.00；SD 7.36）；ES 1.06；90%CI 0.41 至 1.70。探索性的、混杂因素调整的回归模型支持这种初步效果的治疗关联，即减少渴望体验（CEQ-F 系数-28.25；95%CI-45.15 至-11.35）；更多的戒断（PDA 发生率比[IRR]1.56；95%CI 1.31 至 1.88）；和更大的最大戒断（LPA IRR 2.56；95%CI 1.96 至 3.35），尽管相对较弱的未测量混杂因素可能会推翻这些模型调整后的暴露-结局关联。有四起严重不良事件（发生在三名参与者身上）。没有一件被认为与研究程序或干预措施有关。
在可卡因使用障碍的 MFCT 的首次外部试点随机对照试验中，我们已经表明，干预和对照程序是可以接受的、可行的和安全的，并报告了初步证据，表明 MFCT 与减少渴望和增加戒断有关。这些发现支持了进行实质性试验。
英国国家卫生研究院，生物医学研究中心。
