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Pilot Study of Contingency Management for Smoking Cessation

Primary Purpose

Smoking, Tobacco Smoking, Smoking, Tobacco

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Tobacco Smoking, Smoking, Tobacco, Smoking Cessation, Opiate Addiction, Opiate Dependence, Contingency Management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Lorraine Hewitt Hosue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Contingency Management: smoking

Contingency Management: attendance

Arm Description

Contingency Management: smoking Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence

Contingency Management: attendance Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)

Outcomes

Primary Outcome Measures

Number of participants completing treatment in each condition
Number of participants completing treatment in each condition

Secondary Outcome Measures

Percentage of negative samples
Percentage of biochemically verified (exhaled air carbon monoxide) negative breath samples b) Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
Longest duration of abstinence
Number of consecutively biochemically verified (exhaled air carbon monoxide) negative breath samples
Point Prevalence abstinence
Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence

Full Information

First Posted
September 28, 2016
Last Updated
November 27, 2017
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT03015597
Brief Title
Pilot Study of Contingency Management for Smoking Cessation
Official Title
Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Smoking, Smoking, Tobacco, Smoking Cessation, Opiate Addiction, Opiate Dependence
Keywords
Smoking, Tobacco Smoking, Smoking, Tobacco, Smoking Cessation, Opiate Addiction, Opiate Dependence, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management: smoking
Arm Type
Experimental
Arm Description
Contingency Management: smoking Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence
Arm Title
Contingency Management: attendance
Arm Type
Placebo Comparator
Arm Description
Contingency Management: attendance Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Contingency management is a behavioural intervention based on the principals of operant conditioning that is widely used in the addictions field. At the most basic level, contingency management works by providing rewards as reinforcement for desired behaviours. In the current study, the desired behaviours are either attendance at the clinic and abstinence from tobacco smoking, or just attendance at the clinic, dependent on the arm of the trial that participants are randomised to. Participants in the experimental condition will receive shopping vouchers for attending the clinic and providing a breath CO recording of <10ppm. Participants in the control condition will receive shopping vouchers for attending the clinic, regardless of their breath CO recording results.
Primary Outcome Measure Information:
Title
Number of participants completing treatment in each condition
Description
Number of participants completing treatment in each condition
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percentage of negative samples
Description
Percentage of biochemically verified (exhaled air carbon monoxide) negative breath samples b) Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
Time Frame
Each week throughout intervention (weeks 1-6) and at 6 month follow up
Title
Longest duration of abstinence
Description
Number of consecutively biochemically verified (exhaled air carbon monoxide) negative breath samples
Time Frame
Each week throughout intervention (weeks 1-6) and at 6 month follow up
Title
Point Prevalence abstinence
Description
Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
Time Frame
Each week throughout intervention (weeks 1-6) and at 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Insufficient English skills to understand study protocols Currently undergoing treatment for drugs other that opiates or tobacco Taking part in other research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann McNeill, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
Lorraine Hewitt Hosue
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Permission is not being sought for this from participants to expedite recruitment
Citations:
PubMed Identifier
33233020
Citation
Ainscough TS, Brose LS, Strang J, McNeill A. Contingency management for tobacco smoking during opioid addiction treatment: Implementation challenges. Drug Alcohol Rev. 2021 May;40(4):658-661. doi: 10.1111/dar.13216. Epub 2020 Nov 24.
Results Reference
derived

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Pilot Study of Contingency Management for Smoking Cessation

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