Opiate dependency Mental and Behavioural Disorders Mental and behavioural disorders due to use of opioids
Conditions
Interventions
11/04/2013: Please note that this trial was stopped before patient recruitment began.
Suboxone: sublingual tablets with an initial recommended once-daily dose of 0.8?4 mg, adjusted according to resp
60-120mg/d
modal dose range 60-80 mg/d) methadone oral solution [mixture] 1mg/1mL) Methadone induction begins using an initial dose of 10?40 mg daily, which is increased by up to 10 mg daily (with a maximum week
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. Is able to comprehend English to the extent required by the study protocol 3. Demonstrates verbal understanding of the study patient information material, is able to provide written consent, and can understand and confirm willingness to comply with the protocol 4. Current diagnosis of opioid dependence 5. Current opioid tolerance 6. Voluntarily seeking treatment for opioid dependence and able to attend the clinic as described in the protocol 7. Lives in sufficiently stable accommodation in the community, with a personal phone 8. Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments
Exclusion criteria
Exclusion criteria: 1. Clinically significant medical condition (including pregnancy or lactating) or observed abnormalities on physical examination or laboratory investigation, including but not limited to: uncontrolled hypertension; significant heart disease (including myocardial infarction in past 12 months); angina; or any serious, potentially life-threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct; or any ECG/cardiovascular abnormality which, in the investigator?s judgment, is clinically significant. 2. Current criminal justice involvement with legal proceedings and, in the opinion of the Chief Investigator, is expected to fail to complete the study protocol due to incarceration or relocation from the centre?s catchment area. 3. Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt. 4. Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder ? addressed in routine admissions protocol) and/or a history or evidence of organic brain disease or dementia that would compromise the participant?s ability to comply with the study protocol. 5. Is not currently a participant in a research study or has not been in CTIMP research study in the previous 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-report of heroin use or cocaine use during weeks via structured clinical interview and individual diary record, confirmed by rapid-result (on-site) urine screen for morphine and cocaine metabolites. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medication compliance, treatment retention (phase 1 & 2) and psychological therapy adherence rates (phase 2) 2. Heroin craving and cocaine craving for all participants (phases 1 & 2) 3. Relative cost-effectiveness of the different treatment configurations | — |
Countries
United Kingdom
Outcome results
None listed