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临床试验/NCT03015597
NCT03015597已完成不适用

Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study

King's College London1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of participants completing treatment in each condition

研究概览

简要总结

The purpose of this study is to see whether contingency management (CM) can be successfully added as an adjunct treatment to standard stop smoking services in outpatients undergoing treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for opiate addiction will be stratified to a CM intervention for either smoking abstinence or attendance at the clinic, whilst also receiving usual stop smoking services cessation treatment. The intervention will run for five weeks and participants will be followed up six months after the beginning of the study.

详细描述

The study aims to investigate whether a contingency management (CM) intervention can be added to usual NHS stop smoking services (SSS) treatment, in patients undergoing treatment for opiate addiction.

The SSS at the treatment centre follows the standard treatment program set out by the National Centre for Smoking Cessation and Training (NCSCT) and the NICE guidelines for smoking cessation. Service users taking part in the SSS attend one meeting per week for six weeks. In the first meeting with a cessation worker the client completes baseline information about the client's age, gender, ethnicity, employment, motivation to quit, past quit attempts and current smoking behaviour), and sets a quit date for the following week. For the remaining four weeks clients attend the clinic to receive behavioural support. Nicotine replacement therapy (NRT) is available free of charge to all individuals engaged with SSS. During the six weeks of treatment, service users are given a week's supply of NRT at a time. At the end of the six weeks, service users are given a two week supply of NRT before exiting the SSS treatment. NRT use is recorded throughout SSS treatment. Clients' breath carbon monoxide (CO) levels are also measured at the initial visit and at each subsequent visit over the next 5 weeks in order to biochemically verify self-reported abstinence from smoking (CO<10ppm).

The CM intervention that this study will run as an adjunct to the SSS,. The 40 participants will be randomised into either experimental (CM for abstinence) or control (CM for attendance) conditions at intake. Randomisation will be stratified based on participants' current smoking frequency (between 10 and 20 per day, and more than 20 per day). The intervention will run for five weeks in total, with randomisation occurring at visit 1, and the intervention beginning in week two of the SSS treatment and ending in week six. Participants will be rewarded for smoking abstinence in the experimental condition, and for attending the SSS clinic in the control condition. For the experimental condition smoking abstinence will be defined as a breath CO reading of <10ppm, and for the control condition attendance will be defined as attending the SSS clinic once a week. Rewards will be administered by a researcher to ensure cessation workers are not aware of group allocation.

The intervention will employ an 'escalating with reset' schedule, Reward values will be the same in both conditions. In escalating with reset CM, rewards escalate in a set increment value for each successive verified display of the desired behaviour. When the desired behaviour is not observed, no reward is given, and the reward value for the next verified display of the desired behaviour is reset to that of the initial reward. Reward values then begin to rise again in the same way as before.

Six months after their set quit date, participants will be contacted by the PI to ascertain their self-reported smoking status. In order to test the optimal follow up method, participants will be pseudo-randomised to be contacted by text and phone call, or email and phone call. All participants will also be asked to return to the clinic in order to have their breath CO levels tested to verify this. Once this is done, participants will have completed their participation in the study.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Want to quit smoking
  • Between 18 and 65 years old
  • Undergoing current pharmacological treatment for opiate addiction
  • Smoke a minimum of 10 cigarettes per day
  • Provide informed consent.

排除标准

  • Insufficient English skills to understand study protocols
  • Currently undergoing treatment for drugs other that opiates or tobacco
  • Taking part in other research

研究组 & 干预措施

Contingency Management: smoking

Experimental

Contingency Management: smoking

Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence

干预措施: Contingency Management (Behavioral)

Contingency Management: attendance

Placebo Comparator

Contingency Management: attendance

Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)

干预措施: Contingency Management (Behavioral)

结局指标

主要结局

Number of participants completing treatment in each condition

时间窗: 6 weeks

Number of participants completing treatment in each condition

次要结局

  • Point Prevalence abstinence(Each week throughout intervention (weeks 1-6) and at 6 month follow up)
  • Percentage of negative samples(Each week throughout intervention (weeks 1-6) and at 6 month follow up)
  • Longest duration of abstinence(Each week throughout intervention (weeks 1-6) and at 6 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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