Opiate dependency disorder
Conditions
Interventions
Trade Name: Suboxone
Product Name: Suboxone
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
King's College London
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years of age or older (no upper limit, but generally =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinically significant medical condition 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 abnormality which, in the investigator’s judgment, is clinically significant. 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. Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt. 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. Is not currently a participant in a research study or has been in CTIMP research study in the previous 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical and cost effectiveness of a personalised behavioural intervention (PBI) compared to treatment-as-usual (TAU) at achieving heroin and cocaine abstinence and health economic outcomes after 12 weeks of PBI, among initially non-responsive patients enrolled in Opiate Substitution Treatment (methadone [MMT]; Suboxone [SMT] (according to clinical preference) in a specialist NHS addictions treatment centre.;Secondary Objective: A. Are there identical treatment retention and psychological therapy adherence rates between PBI and TAU arms of the study? B. Are there identical heroin and cocaine craving, and other clinical functioning response profiles between the PBI and TAU arms? C. What are the longer-term treatment and addiction recovery outcomes for patients receiving PBI and TAU over 5 years, and can biomarkers of differential clinical response be identified?;Primary end point(s): At week 24 the proportion of patients who are categorised as responder or non-responder. Responders report no use of heroin or cocaine during weeks 21-24 and submit no positive urine drug tests during weeks 21-24 Non-responders report use of heroin or cocaine during weeks 21-24 or submit a positive urine drug tests during weeks 21-24 At week 24 week the relative cost-effectiveness of trial treatments using: EQ5D AD-SUSD;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of this end point (max 800 characters) At weeks 21- 24 after enrollment for urine drug tests and 24 weeks for the EQ5D and AD-SUSD | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Treatment retention (i.e. days from first dose of OST to treatment exit or follow-up point using information help by the clinic’s electronic patient journey database). 2. Heroin and cocaine craving via Minnesota Cocaine [and heroin] Craving Scale (MCCS) and other scale ratings 3. An exploratory analysis of moderation and mediation of treatment response will be also undertake using the following measures: ? BPD ? BPAQ-S ? BIS-11 ? MoCA ? TOP ? WSAS;Timepoint(s) of evaluation of this end point: after enrollment 1. at 24 weeks 2. weeks 4,8,12,14 3. weeks -10, -6, -3, 0, 4, 8, 12,14 | — |
Countries
United Kingdom
Contacts
Public ContactMichael Kelleher
South London & Maudsley NHS Foundation Trust
Outcome results
None listed