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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United Kingdom1 site
  • Lorraine Hewitt Hosue

    London

Other trials in United Kingdom

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.

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 groups in NCT03015597
Study groupRoleWhat they receive
Contingency Management: smokingExperimentalContingency Management: smoking Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence
Receives: Behavioral: Contingency Management
Contingency Management: attendancePlacebo comparatorContingency 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.

  1. Number of participants completing treatment in each condition

    Number of participants completing treatment in each condition

    Measured: 6 weeks

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted10 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

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)
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

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.

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Clinical Trial NCT03015597 | AzTrials