Opiate addiction (detoxification from illicit opiates)
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: Buprenorphine Hydrochloride 0.4mg
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female 18 - 65 years old Using illicit opiates as confirmed by a urine test at first assessment Remaining in the prison estate for longer than 28 days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications to methadone or buprenorphine (subutex) Co-exisiting acute medical conditions requiring emergency admission to hospital care so precluding detoxification in the prison setting Currently undergoing detoxification from other addictive drugs whereby concurrent detoxification from illicit opiates would not be clinically indicated Women who are pregnant or breastfeeding Previously been randomised into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether buprenorphine (subutex) or methadone, given openly to heroin users presenting for detoxification in the UK NHS Prison setting, helps achieve abstinence at completion of the regime;Secondary Objective: To quantify the effects of both agents - buprenorphine (subutex) and methadone - to achieve abstinence from opiates in both the short and medium term (1, 3 and 6 months); Primary end point(s): Medication end point - 21 days Urine test - 26 days 1 month follow up (data collection) - 1 month plus 26 days 3 month follow up (data collection) - 3 month plus 26 days 6 month follow up (data collection) - 6 month plus 26 days | — |
Countries
United Kingdom
Outcome results
None listed