Supporting alcohol consumers to reduce their drinking with contingency management
| ISRCTN | ISRCTN48226844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48226844 |
| IRAS number | 338990 |
| Secondary identifying numbers | MR/W028476/1, IRAS 338990, CPMS 60386 |
- Submission date
- 08/04/2024
- Registration date
- 16/04/2024
- Last edited
- 16/04/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Contingency management (CM) is a behaviour modification technique that rewards desired behaviours such as abstinence from alcohol by providing incentives. Systematic reviews confirm that it is effective for people with addictions including alcohol use disorders. CM may help people to reduce drinking because it will change the way that they make decisions about alcohol and about other things such as engaging in hobbies, family time, work and so on. This study aims (i) to investigate if a three-week CM intervention can help risky drinkers reduce their alcohol consumption, and (ii) to characterise the value-based decision-making mechanisms that underlie this effect.
Who can participate?
Healthy adults aged 21 years old and over who currently drink 28 or more alcohol units per week and want to cut down
What does the study involve?
This is a study in which adults who drink at a risky level will be recruited from the local community and randomly assigned to receive either daily CM or a control intervention over three weeks. Participants receiving CM will get payments according to their abstinence from alcohol (as verified by cellular breathalysers). Control participants will also receive payments but these will be “yoked” to participants assigned to CM, therefore for participants in the control group these payments will not be contingent upon their alcohol consumption. The research will measure participants’ value-based decision-making immediately before and immediately after the intervention period, and at one-month follow-up.
What are the possible benefits and risks of participating?
Benefits: This work will contribute to tailoring treatments and advice for people who want to reduce their alcohol consumption. People who take part in the study will also receive shopping vouchers as a thank you. The way that payments are determined will be explained after participants have been screened and randomised to the experimental group.
Risks: People who are invited to take part in the study after initial screening are unlikely to experience serious negative side effects if they were to stop drinking. However, answering some of the questions may make them concerned about their drinking.
Where is the study run from?
The University of Sheffield
When is the study starting and how long is it expected to run for?
October 2022 to October 2025
Who is funding the study?
Medical Research Council
Who is the main contact?
Prof Matt Field, matt.field@sheffield.ac.uk
Contact information
Public, Scientific, Principal Investigator
Department of Psychology
University of Sheffield
ICOSS building
219 Portobello
Sheffield
S1 4DP
United Kingdom
 ORCID ID |
0000-0002-7790-5559 |
|---|---|
| Phone | +44 (0)114 2226510 |
| matt.field@sheffield.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Laboratory |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Changes in alcohol use and value-based decision-making in alcohol use disorder during and after contingency management treatment: a randomised controlled trial |
| Study hypothesis | The primary hypotheses are: 1. Participants randomised to CM will have a higher percentage of abstinent days over the three-week intervention period, compared to participants randomised to control (primary outcome 1) 2. In participants randomised to CM (relative to participants randomised to control), evidence accumulation (EA) rates for alcohol-free reinforcement will increase, whereas EA rates for alcohol reinforcement will decrease, from baseline to post-intervention (primary outcome 3. In participants randomised to CM (relative to participants randomised to control), response thresholds (RT) for alcohol-free reinforcement will decrease, whereas RT for alcohol reinforcement will increase, from baseline to post-intervention (primary outcome 3) 4. In participants randomised to CM (relative to participants randomised to control), the percentage alcohol choice on the concurrent choice task will decrease from baseline to post-intervention (primary outcome 4) The secondary hypotheses are: 5. At one-month follow-up, participants randomised to CM will report reduced quantity (secondary outcome 1) and frequency (secondary outcome 2) of alcohol consumption, compared to participants randomised to control (secondary outcomes 1 and 2) 6. At one-month follow-up, EA for alcohol-free reinforcement will be higher, whereas EA for alcohol reinforcement will be lower, in participants randomised to CM relative to participants randomised to control (secondary outcome 3) 7. At one-month follow-up, RT for alcohol-free reinforcement will be lower, whereas RT for alcohol reinforcement will be higher, in participants randomised to CM relative to participants randomised to control (secondary outcome 4) 8. At one-month follow-up, the percentage alcohol choice on the concurrent choice task will be lower in participants randomised to CM relative to participants randomised to control (secondary outcome 5) 9. Changes in aforementioned value-based decision-making (VBDM) parameters and % alcohol choice from baseline to post-intervention will partially mediate group differences in the percentage of abstinent days over the three-week intervention period. 10. Changes in VBDM parameters and % alcohol choice from baseline to follow-up will partially mediate group differences in the quantity and frequency of alcohol consumption over the corresponding period. 11. Individual differences in VBDM parameters and % alcohol choice at baseline will moderate the effect of group assignment on the percentage of abstinent days over the three-week intervention period. 12. Individual differences in VBDM parameters and % alcohol choice at baseline will moderate the effect of group assignment on the quantity and frequency of alcohol consumption at follow-up. |
| Ethics approval(s) |
Approved 05/04/2024, Department of Psychology Research Ethics Committee (Department of Psychology, ICOSS building, University of Sheffield, 219 Portobello, Sheffield, S1 4DP, United Kingdom; +44 (0)114 222 6533; psy-ethics@sheffield.ac.uk), ref: 059456 |
| Condition | Treatment of alcohol use disorder |
| Intervention | Contingency management: Intervention is delivered in the community. Participants breathalyse themselves with a cellular breathalyser (which takes their photo as they provide the breath sample), and they transmit the readings to the research team. They do this three times per day during the three-week intervention period. For each day of verified abstinence from alcohol, participants receive a payment. This is £5 for the first day of verified abstinence and it increases by £1 for each consecutive day of verified abstinence, up to a maximum of £15. If participants drink alcohol, the payment resets to zero on that day and then restarts at £5 on the next day of verified abstinence. Participants receive a summary of the total payment at the end of each week of the intervention period, and they receive payments in the form of shopping vouchers at the end of the intervention period. Comparator: Intervention is delivered in the community. Each participant in the control group is "yoked" to a participant in the contingency management group. Participants breathalyse themselves with a cellular breathalyser (which takes their photo as they provide the breath sample), and they transmit the readings to the research team. They do this three times per day during the three-week intervention period. Payments are unrelated to their alcohol consumption but are instead matched to those awarded to the participant in the contingency management group to whom they are yoked. Participants receive a summary of the total payment at the end of each week of the intervention period, and they receive payments in the form of shopping vouchers at the end of the intervention period. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Percentage of abstinent days over the three-week intervention period (as verified by cellular breathalyser) 2. Evidence accumulation rates for alcohol and alcohol-free reinforcement (inferred from value-based decision-making task) at post-intervention 3. Response thresholds for alcohol and alcohol-free reinforcement (inferred from value-based decision-making task) at post-intervention 4. Percentage alcohol choice on the concurrent choice task at post-intervention |
| Secondary outcome measures | 1. Quantity and frequency of self-reported alcohol consumption at one-month follow-up 2. Evidence accumulation rates for alcohol and alcohol-free reinforcement at one-month follow-up 3. Response thresholds for alcohol and alcohol-free reinforcement at one-month follow-up 4. Percentage alcohol choice on the concurrent choice task at one-month follow-up |
| Overall study start date | 01/10/2022 |
| Overall study end date | 30/10/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Sex | Both |
| Target number of participants | 140 |
| Participant inclusion criteria | 1. Adults aged 21 years or above 2. Currently consume 28 or more alcohol units per week 3. Want to cut down on drinking |
| Participant exclusion criteria | 1. Drinking alcohol in a way that would increase the risk of experiencing withdrawal symptoms if were to suddenly stop drinking alcohol 2. Pregnancy or attempting to become pregnant 3. Any history of treatment for an alcohol use disorder (alcoholism) or received advice from a GP or other health professional to seek treatment |
| Recruitment start date | 22/04/2024 |
| Recruitment end date | 07/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield
S10 2TN
United Kingdom
Sponsor information
Government
Polaris House
North Star Avenue
Swindon
SN2 1FL
England
United Kingdom
| Phone | +44 (0)1793 444164 |
|---|---|
| nmhb@mrc.ukri.org | |
| Website | https://www.ukri.org/councils/mrc/ |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and analysed during the current study will be stored in a publicly available repository. Upon publication of results from this study in a peer-reviewed journal, or before the 31st December 2025 (whichever is sooner), aggregated, anonymised data selected for long-term preservation and sharing will be deposited in the UK Data Service. The UK Data Service is openly accessible and searchable and will guarantee the preservation of these data for ten years or more. Metadata records describing these data will also be stored in ORDA (https://orda.shef.ac.uk/), the University of Sheffield research data registry and repository. The anonymised data may also be uploaded to other publicly accessible repositories such as ResearchBox or the Open Science Framework. Governance of access: Data will be made available through shared research platforms (UK Data Archive and ORDA) with the relevant permissions in place. The study team’s exclusive use of the data: The project group (including Project Partners) will have exclusive use of the data until the main research findings are published. Regulation of responsibilities of users: External users will be bound by data-sharing agreements as specified by the MRC Data Sharing Policy. These will include provisions that data are not shared with third parties without permission, and that credit is given to the research group that produced the data. Anybody who wishes to access the data from the UK Data Service will be required to sign a license agreement that permits the UKDS to perform its curatorial functions and make the data available via a Creative Commons Licence. Participants provided their informed consent for sharing their anonymised data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (other) | 16/04/2024 | 16/04/2024 | No | No |
Editorial Notes
09/04/2024: Study's existence confirmed by the University of Sheffield.
