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临床试验/NCT03656653
NCT03656653Unknown不适用

Clinical Study of Imagery-based Coping for Cocaine Use Disorder

King's College London2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Changes in Number of Days abstinent from Cocaine

研究概览

简要总结

A pragmatic, 4-week, 4-group, between-subjects, factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery (of past and future positive [recovery oriented] and negative [cocaine aversive] events) can help reduce cue-induced cocaine craving and cocaine use.

详细描述

Cocaine, a powerful stimulant drug, is used by 2.2% of people aged 16-59 in England and each year about 150.000 people seek help for cocaine use disorder from the NHS or non-governmental organisations (NGO). There are currently no approved medication-assisted treatments or specific psychosocial interventions for CUD. General counselling is offered by the NHS and NGO addiction services, but this is not particularly effective.

The transition from regular cocaine use to cocaine abuse is often marked by intense episodes (binges), which may last several days and are followed by a 'crash' with no or little use. For many people, repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content. Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary, distressing and uncontrollable.

Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations. The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD. Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence.

Craving-related experiences are informed by memories of intense reward, physical sensations and include pro-drug beliefs, appraisals, expectancies and vivid mental imagery. Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour. If impeded or delayed, drug imagery highlights a deficit and can be experienced as distressing and intrusive. Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting. Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving. Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours.

This will be a pragmatic, 4-week, 2x2, between-subjects, factorial randomised controlled trial. It will be conducted at a specialist NHS outpatient addictions clinic (Lorraine Hewitt House; LHH) operated by South London and Maudsley NHS Foundation trust (SLaM) and at the NIHR Wellcome Trust King's Clinical Research Facility (CRF) at King's College Hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (18 years and over; no upper limit);
  • English speaking (to a level sufficient to engage with a psychosocial intervention);
  • Current diagnosis for primary CUD alone, with concurrent opiate use disorder or while enrolled in opioid agonist therapy *
  • Self-reported regular use of crack cocaine;
  • Stated motivation to reduce or quit cocaine use;

排除标准

  • Current post-traumatic stress disorder (PTCI score >100);
  • Suicide attempt in the past 3 months;
  • Participants with harmful alcohol consumption (>50 units per week men; >35 units women);
  • Cocaine hydrochloride (powder form) users; **
  • Non-English Speaking;
  • Clinically significant on-going medical problems that might make participation unsafe;
  • Uncontrolled Mental Health Disorder;
  • Severe neurocognitive impairment (Montreal Cognitive Assessment <17);
  • Current enrolment in an addiction treatment related clinical research study

研究组 & 干预措施

Future-based recovery-oriented imagery

Experimental

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future without cocaine use

干预措施: Mental Imagery for Craving Reduction (Behavioral)

Future-based cocaine-aversive imagery

Experimental

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future where cocaine is causing significant distress

干预措施: Mental Imagery for Craving Reduction (Behavioral)

Past recovery-oriented imagery

Experimental

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event without cocaine use

干预措施: Mental Imagery for Craving Reduction (Behavioral)

Past cocaine-aversive imagery

Experimental

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event where cocaine use has caused significant distress

干预措施: Mental Imagery for Craving Reduction (Behavioral)

结局指标

主要结局

Changes in Number of Days abstinent from Cocaine

时间窗: baseline (Week 0) and at two week-follow up (Week 4)

The primary outcome measure will be number of days abstinent from cocaine (percentage). A higher percentage indicates a higher number of abstinent days from cocaine. This will be expressed as the cumulative distribution function for change (between baseline and follow-up) using a Timeline Follow Back method (calendar prompt). Percentage days abstinent is measured for two weeks before the first assessment and two weeks post craving-induction procedure.

次要结局

  • Change from baseline in Craving Experience Questionnaire Score (CEQ-12)(baseline (Week 0) and at two week-follow up (Week 4))
  • Imagery Monitoring Diary(Diary assessed at two-week follow up (Week 4))
  • Obsessive Compulsive Drug Use Scale (OCDUS)(Week 1 ( Assessment))
  • Heart Rate Variability (HRV)(Week 2; 2 hour session)
  • Urine toxicology Screening (UDS)(Assessed at two-week follow up (Week 4))
  • Episodic Foresight Score (EFS)(EFS is assessed during the assessment session (Week 1))
  • Predominance of verbal and imagery-based thoughts visual analogue scale (PV-IT)(Week 2 ( x2; Post Craving Induction; Post Imagery Intervention))
  • Substance Related Imagery Semi Structured Interview (SRI)(Week 1 (Assessment))
  • Electrodermal Activity (EDA)(Week 2; 2 hour session)
  • The Positive and Negative affect Schedule (PANAS)(Week 2 ( Post Imagery Intervention))
  • Patient Health Questionnaire (PHQ-9)(Week 1 (Assessment))
  • Temperature(Week 2; 2 hour session)
  • Generalised Anxiety Disorder Assessment (GAD-7)(Week 1 (Assessment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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