Facilitating opiate recovery: withdrawal and abstinence through detoxification support
Opioid dependency
Intervention arm: after randomisation, which will take place using Sealed Envelope within OpenClinica, participants will be titrated up to a minimum of 10 mg baclofen TID, to be taken orally, up to a maximum of 20 mg TID over a period of 7-12 days. Study medication will be taken in addition to the prescribed methadone dose, for up to 12 weeks, or less if abstinence is achieved earlier. During this time participants will complete weekly follow-up questionnaires and attend in-person visits every three weeks. At the end of the study, participants will be tapered off baclofen over a period of 7-10 days, attend an exit visit and provide follow-up data on methadone dose for up to 3 months following trial exit. Control arm: after randomisation, which will take place using Sealed Envelope within OpenClinica, participants will be titrated up to a minimum of three placebo tablets TID, to be taken orally, up to a maximum of six placebo tablets TID over a period of 7-12 days. Study medication will be taken in addition to the prescribed methadone dose, for up to 12 weeks, or less if abstinence is achieved earlier. During this time participants will complete weekly follow-up questionnaires and attend in-person visits every 3 weeks. At the end of the study, participants will be tapered off placebo over a period of 7-10 days, attend an exit visit and provide follow-up data on methadone dose for up to 3 months following trial exit.
1. Classified or determined by their addiction service as ready for dose reduction or detox 2. >18 years old 3. Current or previous DSM-5 moderate to severe opioid use disorder or ICD10/11 opioid dependence 4. Currently treated with methadone substitution therapy 5. The client wishes to undergo methadone detoxification and/or dose reduction
1. Lack of capacity to consent 2. Unable to take oral medication 3. Contraindication for baclofen, as per SmPC guidance 4. History of allergic or adverse reactions to baclofen, or placebo, or any of their excipients 5. Where there are "Special warnings and precautions for us" according to the SmPC AND where the risk vs benefit ratio for prescribing is not in favour of prescribing medication (see SmPC) 6. Current and ongoing substance dependence (including alcohol), except for opiates and nicotine, with no desire to stop at this time 7. Clinician does not deem that the individual is suitable to undergo dose reduction or detoxification from methadone at this time 8. Use of regular prescription or illicit medications or drugs which in the opinion of the investigators will interfere with subject safety or study integrity 9. Severe chronic obstructive pulmonary disease or Type 2 respiratory failure 10. Unable to follow the study protocol due to serious mental health disorder e.g. enduring psychotic illness, suicidal intent 11. Any woman who is pregnant, of child-bearing potential refusing a pregnancy test or unwilling to use adequate contraception for the duration of the trial