Randomised controlled trial of injectable opioid treatment for heroin dependence (RIOTT) - RIOTT

Phase 1

• Conditions: Opioid dependence, ICD classification code F11.2 (ICD-10)

• Registration Number: EUCTR2004-003175-36-GB
• Lead Sponsor: Kings College London/South London and Maudsley NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. aged between 18-65 years at recruitment to study
2. at least 3-year history of injecting heroin use sufficient to meet DSM-IVR criteria
3. in continuous methadone treatment for at least 6 months this episode
4. regular injecting heroin use in preceding 3 months as evidenced by opiate -positive urine drug screens and patient self-report in clinical notes, use of heroin on at least 50% of days in the preceding month on self-report (>14 days in past 4 weeks), and evidence of regular injecting on clinical examination.
5. able and willing to participate in the study procedures (eg. no impending prison sentence ) and provide informed consent.
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

1. no active significant medical (eg. severe hepatic dysfunction) or psychiatric condition (psychosis, severe affective state), as determined by study medical officer.
2. not alcohol dependent or abusing benezodiazepines according to DSM-1VR criteria.
3. Not pregnant, breatfeeding, or planning to become pregnant during the study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified