SmokingNCT03015597
Pilot Study of Contingency Management for Smoking Cessation
A study testing Contingency Management in people with Smoking and Tobacco Smoking, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking, Tobacco Smoking, Smoking, Tobacco
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Insufficient English skills to understand study protocols
- Currently undergoing treatment for drugs other that opiates or tobacco
- Taking part in other research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study
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.
Read the 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.
- Conditions
- Smoking, Tobacco Smoking, Smoking, Tobacco, Smoking Cessation, Opiate Addiction, Opiate Dependence
- Being tested
- Contingency Management
- Keywords
- Smoking, Tobacco Smoking, Smoking, Tobacco, Smoking Cessation, Opiate Addiction, Opiate Dependence, Contingency Management
- Medical subject headings
- Smoking, Tobacco Smoking, Smoking Cessation, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management: smoking | Experimental | Contingency Management: smoking
Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence Receives: Behavioral: Contingency Management |
| Contingency Management: attendance | Placebo comparator | Contingency Management: attendance
Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status) Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing treatment in each condition
Number of participants completing treatment in each condition
Measured: 6 weeks
Secondary outcomes (3)
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
Measured: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Longest duration of abstinence
Number of consecutively biochemically verified (exhaled air carbon monoxide) negative breath samples
Measured: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Point Prevalence abstinence
Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
Measured: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann McNeill, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015597
- Sponsor's protocol ID
- 171709
- Status last verified
- Dec 2016
- First submitted
- 28 Sep 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Permission is not being sought for this from participants to expedite recruitment
Publications
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.
PubMed 33233020
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03015597
- Acronym / sponsor ID
- 171709
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management: smoking | Experimental | Behavioral: Contingency ManagementContingency Management: smoking Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence |
| Contingency Management: attendance | Placebo comparator | Behavioral: Contingency ManagementContingency Management: attendance Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Insufficient English skills to understand study protocols
- Currently undergoing treatment for drugs other that opiates or tobacco
- Taking part in other research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementContingency 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. | Behavioural | Contingency Management: attendance, Contingency Management: smoking |
Primary outcome
Number of participants completing treatment in each condition
Time frame: 6 weeks
Number of participants completing treatment in each condition
3 secondary outcomes
Percentage of negative samples
Time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Longest duration of abstinence
Time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Point Prevalence abstinence
Time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Derived from this study: PubMed 33233020Ainscough 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.
- Individual participant dataSharing planned: No. Permission is not being sought for this from participants to expedite recruitment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann McNeill, PhD study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Smoking and Tobacco Smoking, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing treatment in each condition (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.