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TADAM, a Belgian project of Heroin-Assisted Treatment - TADAM

TADAM, a Belgian project of Heroin-Assisted Treatment - TADAM

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019026-13-BE
Enrollment
200
Registered
2010-03-29
Start date
2010-05-06
Completion date
Unknown
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

treatment resistant heroin addiction

Interventions

Trade Name: Diacetylmorfine, poeder voor inhalatiedamp (75 mg, 100 mg, 150 mg and 200 mg) Product Name: Diacetylmorphine Product Code: Diacetylmorphine Pharmaceutical Form: Inhalation powder INN or Pr

Sponsors

University of Liège
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Treatment-resistant heroin dependency, as indicated by: - heroin dependency for at least 5 years, - heroin addiction is the main dependency, - daily or almost daily use of illicit heroin, - previous experience of methadone treatment, Legal resident in the judicial district of Liège for at least 12 months, A minimum age of 20 years, Willing to attend the treatment site at least twice a day, Willing to attend a psychosocial follow-up Written 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

Exclusion criteria: Persons who had voluntary phase of abstinence of at least 2 months during the last 12 months Pregnancy Diagnosis of severe medical or psychiatric conditions that are contra-indicated for the study conditions

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison of the efficacy of a heroin-assisted treatment versus existing treatments;Secondary Objective: Comparison of the feasibility and cost-effectiveness of diacetylmorphine assisted treatment versus existing treatments;Primary end point(s): The better efficacy will be shown by a higher number of responders in a group. A responder is a patient who shows after 12 months a better health (physical or mental) and/or a decrease in street heroin use and/or a decrease in criminal behaviour.

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026