FORWARDS-2. Facilitating Opiate Recovery: Withdrawal and Abstinence through Detoxification Support
Research type
Research Study
Full title
Facilitating Opiate Recovery: Withdrawal and Abstinence through Detoxification Support (2)
IRAS ID
1007293
Contact name
Anne Lingford-Hughes
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN98180939
Research summary
Opioid addiction remains a major challenge in the UK. Opioid substitution therapy (OST), usually methadone, is associated with reduced illicit heroin use and health improvements. When someone desires abstinence, their methadone dose is gradually reduced over weeks to reduce risk of withdrawal symptoms. However, many find ‘detoxification’ difficult to tolerate due to sleep disturbance, anxiety and fear of experiencing withdrawal. These symptoms can be eased with medications, such as lofexidine, but it is no longer available in the UK so new treatments are needed.
Evidence suggests that a GABA-B agonist, baclofen, may be helpful in reducing opiate withdrawal symptoms. Baclofen is a licensed medication to treat muscle spasms. The FORWARDS-1 study established that individuals on methadone (up to 70mg/d) could safely take 60mg of baclofen. This trial, FORWARDS-2, is investigating whether baclofen can help people reduce or stop their methadone.
112 opioid dependent participants who wish to undergo dose reduction or detoxification from methadone will take part. Participants will be randomised to receive baclofen or placebo, alongside usual treatment. Baclofen will be titrated up over 7-10 days to achieve a maintenance dose of 30-60mg/d for up to 12 weeks. Participants will attend regular in-person visits and complete weekly brief questionnaires about how they are feeling while taking the study medication. Methadone dose, medication compliance, side effects and feasibility measures will be recorded at each visit. After 12 weeks every participant will have their study medication withdrawn over 7-14 days then complete an exit questionnaire about their experience of the trial. With consent, we will contact them 3 months later to see how they are. If the trial is shown to be feasible and baclofen shows promise as a medication to assist detoxification or dose reduction, we will design a full trial to test its effectiveness.
REC name
West of Scotland REC 1
REC reference
23/WS/0064
Date of REC Opinion
12 Oct 2023
REC opinion
Further Information Favourable Opinion