Opioid dependency Mental and Behavioural Disorders Mental and behavioural disorders due to use of opioids
Conditions
Interventions
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
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in methadone dose with baclofen compared with placebo at 12 weeks, or time of abstinence if sooner. The difference in methadone dose will be measured by calculating the difference in methadone dose (in mg) at baseline compared with 12 weeks (or time of abstinence). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Successful abstinence, defined as the first instance of a reduction in methadone dose to 0 mg for 3 or more days between initiation of study treatment and the end of the 12-week maintenance period 2. Time to successful abstinence measured between initiation of study treatment and the first instance of a reduction in methadone dose to 0 mg for 3 or more days up to the end of the 12-week maintenance period 3. Days of abstinence from methadone between initiation of study treatment and the end of the 12-week maintenance phase or until time of successful abstinence if earlier, measured using the total number of days 0 mg methadone taken as reported by patients using electronic data capture (ePRO). 4. Number of methadone dose changes from initiation of study treatment up to end of the 12-week maintenance period or until time of successful abstinence if earlier, as measured by (i) patient report and (ii) prescribing service. 5. Methadone dose regardless of any period of abstinence, measured using prescribed methadone dose at Week 12, extracted from clinical records 6. Maximum baclofen/placebo dose administered during the 12-week maintenance phase or from the start of the maintenance phase to the time of successful abstinence if earlier, as measured by (i) patient report and (ii) prescribing service. 7. Proportion of time over the 12-week maintenance phase or from the start of the maintenance phase till the time of successful abstinence if earlier at (a) minimum target dose of baclofen/placebo (10 mg tds) and (b) maximum target dose (20 mg tds) as measured by (i) patient report and (ii) prescribing service. 8. Patient rating of psychological health, physical health and overall quality of life in last 7 days at 12 weeks or time of successful abstinence if earlier, measured using the Treatment Outcomes Profile (TOP) 9. Patient rating of craving, measured using 0 to 100 visual analogues scales (VAS-Need and VAS-Want) for heroin and cocaine in the last 7 days at 12 weeks or | — |
Countries
England, United Kingdom
Contacts
Public ContactLouise Paterson
Outcome results
None listed