ADAM: Alcohol dependence and adherence to medicine
| ISRCTN | ISRCTN17083622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17083622 |
| Secondary identifying numbers | CPMS 19571 |
- Submission date
- 16/09/2015
- Registration date
- 16/09/2015
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Alcohol dependence, also called alcoholism, is a growing problem worldwide. When a person becomes physically or mentally dependent on alcohol, it can be very difficult to stop. Acamprosate is a medication which works by reducing cravings for alcohol. When taken as directed, it can be very effective at making sure people do not start drinking again. Many people who are prescribed it do not take it consistently however, which reduces its effectiveness. Medication management (MM) is a programme designed to help people to following their medication treatment plans. It works by providing support and advice, as well as educating people about their drinking behaviours and the importance of taking their medication. MM has been used to help support people take their medication in clinical trials but not in routine care. Contingency management (CM) uses rewards, such as small financial incentives, to encourage people to stick to their treatment plans. There is evidence that these techniques are effective for treating drug addiction, however there is limited research exploring its effectiveness in alcohol dependency. The aim of this study is to find out if MM and CM are effective in helping alcohol dependent people follow their acamprosate treatment plans.
Who can participate?
Alcohol dependent adults who are currently sober, and are being treated with acamprosate.
What does the study involve?
Participants are randomly allocated into three groups. The first group receives standard care only for the entire study period. Participants in the second group receive standard care in addition to 12 MM sessions over a 6 month period. Participants in the third group receive standard care and the 12 MM sessions, but they are also given incentives in the form of vouchers for attending the MM sessions, as part of a CM programme.
What are the possible benefits and risks of participating?
A potential benefit is that if the interventions are successful in improving acamprosate adherence, then it could decrease the risk of alcohol relapse. This could help will long-term alcohol abstinence, leading to improvements in health and quality of life. Risks of participating are minimal. There is a possibility of psychological discomfort when completing the questionnaires, however the potential benefits are believed to outweigh this risk.
Where is the study run from?
National Addiction Centre (UK)
When is the study starting and how long is it expected to run for?
September 2015 to November 2020 (updated 03/09/2020, previously: May 2020)
Who is funding the study?
National Addiction Centre (UK)
Who is the main contact?
Dr Kim Donoghue
kim.donoghue@ucl.ac.uk
Contact information
Public
Department of Clinical, Educational and Health Psychology
University College London
London
SE5 8BB
United Kingdom
 ORCID ID |
0000-0002-7316-1716 |
|---|---|
| Phone | +44 (0)20 7679 1897 |
| kim.donoghue@ucl.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A three-arm randomised controlled trial of the effectiveness and cost-effectiveness of adjunctive medication management and contingency management to enhance adherence to medications for relapse prevention in alcohol dependence |
| Study acronym | ADAM |
| Study hypothesis | The aim of this study is to improve the adherence to acamprosate in order to maximise the benefits for patients. |
| Ethics approval(s) | NRES Committee East of England - Cambridge South, 17/09/2015, 15/EE/0308 |
| Condition | Alcohol dependence |
| Intervention | Contingency Management (CM), Providing small financial or other incentives to change behaviour and/or engage with treatment. Incentives in the form of vouchers will be provided to reinforce attendance at the Medication Management sessions that are delivered by telephone with the pharmacist.; Medication Management (MM), MM is an intervention to help improve medication and treatment adherence by providing education, support and advice to patients about their drinking behaviours and medication. In this study, it will be delivered by specially trained pharmacists via a central telephone support service. Participants are randomly allocated into three groups: Group 1: Standard support only Group 2: Standard support with Medication Management (MM) Group 3: Standard support with Medication Management (MM) and Contingency Management (CM) Participants receiving MM will receive 12 sessions over a 6 month period (weekly for 6 weeks, fortnightly for 6 weeks and monthly for 3 months). |
| Intervention type | Other |
| Primary outcome measure | Proportion of medication taken as prescribed measured using Medication Events Monitoring (MEMS) Cap, pill count and self reporting over 24 weeks. |
| Secondary outcome measures | 1. Alcohol related problems, severity of dependence and cravings measured using the alcohol problems questionnaire (APQ), the severity of alcohol dependence questionnaire (SADQ) and the Alcohol Urge Questionnaire (AUQ) 6 months post randomisation 2. Economic status measured using the Health related Quality of life (EQ-5D-5L) and Adult service use (modified ADSUS) at 6 and 12 months 3. Process outcomes measured using beliefs about medication questionnaire (BMQ) at baseline and 6 months, and scale to assess relationships (STAR) at 6 months 4. Proportion of prescribed medication taken measured using self reporting at 12 months post randomisation 5. Time to first drink, relapse to heavy drinking, relapse to any drinking measured using self reporting at 12 months post randomisation 6. Total alcohol consumed, drinks per drinking day and percentage of abstinence measured over the past 90 days using the timeline follow-back method at 6 and 12 months post randomisation |
| Overall study start date | 01/12/2014 |
| Overall study end date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 748; UK Sample Size: 748; Description: Participants will be randomised to one of three trail arms in the order of 2:1:1;1. Standard support N = 374,2. Standard support plus medication management N = 1873. Standard support plus medication management with contingency management N = 187 |
| Total final enrolment | 739 |
| Participant inclusion criteria | 1. Aged 18 years or over 2. Diagnosis of alcohol dependence 3. Currently alcohol abstinent 4. Prescribed acamprosate by treating clinician |
| Participant exclusion criteria | 1. Severe physical/mental illness likely to preclude active participation in treatment or follow up 2. Current participation in another trial 3. Unable to adequately understand verbal English 4. Currently dependent on an illicit substance |
| Recruitment start date | 30/09/2015 |
| Recruitment end date | 11/06/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Denmark Hill
London
SE5 8BB
United Kingdom
Sponsor information
Hospital/treatment centre
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 4UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Preliminary qualitative work has been completed to inform the trial protocol. This includes four focus groups with service users and four focus groups with pharmacists. It is planned to publish the results of this work in a peer reviewed journal in the later part of 2015. A plain language summary of the research and it’s results will also be developed and disseminated to those who took part in the research, service user research groups and to the general public via the study webpage. The primary results of the full trial will be published in a peer reviewed journal, open-access following completion of the 12 month follow-up in approximately December 2018. A plain language summary will be produced and disseminated to those who took part in the research and service user groups. There are also plans for the research to be disseminated via national, international and service user led conferences. |
| IPD sharing plan | Trial data will be stored securely by King's College London. All data requests should be submitted to the Chief Investigator for consideration. Access to anonymised data may be granted following review. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/10/2023 | 06/11/2023 | Yes | No |
Editorial Notes
06/11/2023: Publication reference added.
14/01/2021: IPD sharing statement added.
08/01/2021: Contact details updated, total final enrolment added.
18/12/2020: Internal review.
03/09/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2020 to 30/11/2020.
2. The intention to publish date was changed from 31/05/2021 to 30/11/2021.
3. The plain English summary was updated to reflect these changes.
03/04/2019: The condition has been changed from "Topic: Mental Health, Primary Care; Subtopic: Addictions, Mental Health; Disease: Addictions, Addictive Substances– alcohol, All Diseases" to "Alcohol dependence" following a request from the NIHR.
12/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2019 to 11/06/2019.
2. The intention to publish date was changed from 01/12/2018 to 31/05/2021.
22/11/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/09/2017 to 28/02/2019.
2. The overall trial end date was changed from 30/11/2017 to 31/05/2020.
