Condition category
Mental and Behavioural Disorders
Date applied
16/09/2015
Date assigned
16/09/2015
Last edited
18/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 September 2017

Who is funding the study?
National Addiction Centre (UK)

Who is the main contact?
Dr Kim Donoghue

Trial website

http://www.kcl.ac.uk/ioppn/depts/addictions/research/alcohol/ADAM-Alcohol-Dependence-and-Adherence-to-Medications.aspx

Contact information

Type

Public

Primary contact

Dr Kim Donoghue

ORCID ID

http://orcid.org/0000-0002-7316-1716

Contact details

National Addiction Centre
4 Windsor Walk
Denmark Hill
London
SE5 8BB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19571

Study information

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

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

NRES Committee East of England - Cambridge South, 17/09/2015, 15/EE/0308

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health, Primary Care; Subtopic: Addictions, Mental Health; Disease: Addictions, Addictive Substances– alcohol, All Diseases

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2014

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

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

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

29/09/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Addiction Centre
4 Windsor Walk Denmark Hill
London
SE5 8BB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

01/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes