heroin dependency cocaine addiction heroin-assisted treatment contingency managemen heroïne-afhankelijkheid cocaïne verslaving behandeling met heroïne op medisch voorschrift contingentie management
Conditions
Interventions
Control group: Heroin-assisted treatment alone.
Subjects assigned to heroin-assisted treatment alone will receive a treatment offer of injectable or inhalable heroin (maximum of 400 mg per prescripti
Sponsors
Central Committee on the Treatment of Heroin Addicts (CCBH), Utrecht University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Treatment-resistant heroin dependency, as indicated by: a. a history of heroin dependency (DSM-IV) of at least five years; b. a minimum dose level of 50 mg (inhaling heroin) or 60 mg (injecting heroin) of methadone per day for an uninterrupted period of at least four weeks in the previous five years; c. in the previous year registered in a methadone program, and during the previous six months in regular contact with the methadone program; d. chronic heroin addiction and unsuccessfully treated in methadone maintenance treatment; e. daily or nearly daily use of illicit heroin; f. poor physical, and/or mental, and/or social functioning. 2. Clinically relevant cocaine use, as indicated by: a. at least one cocaine-positive urine sample during the 4-8 weeks qualification period prior to the start of the heroin-assisted treatment, and b. at least four days of cocaine use in the month preceding the start of the heroin-assisted treatment, according to self-report, and c. at least two cocaine-positive urine samples in the month preceding the start of the experimental or control treatment. During this month, a total of 12 urine samples will be requested, of which a minimum of 10 samples must be provided by the patient, and d. at least four days of cocaine use in the month preceding the start of the experimental or control treatment, according to self-report. 3. Heroin is used through intravenous injection or inhalation. 4. At least 25 years old. 5. Citizen or legal resident in the Netherlands. 6. Registered as a resident in the city area of the treatment site for at least three years. 7. Willing and able to attend the treatment site for the required study assessments and other procedures. 8. Willing to attend the treatment site at least three days a week. 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Not meeting all inclusion criteria. 2. Severe medical, psychiatric or psychosocial problems which constitute a contra-indication for participation. 3. Severe medical, psychiatric or psychosocial problems which may interfere with the conduct of the study. 4. A history of aggressive behavior which is expected to interfere with the conduct of the study and/or the participation in the study of other subjects. 5. Pregnancy or continued lactation, or desire to become pregnant in the near future. 6. Unwilling to attend the treatment site for the required assessments. 7. The heroin dependency is of secondary importance compared to an existing non-opiate dependency. 8. The patient is unwilling to use the prescribed heroin in the treatment site. 9. A period of voluntary heroin abstinence of at least two months in the previous year. 10. Patients requiring a dose of prescribed heroin exceeding 1000 mg per day. 11. Patients unable to understand the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the maximum number of consecutive weeks of cocaine metabolite-free urine samples during the first six months of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include (1) the percentage of responders at the month 6 time-point of the RCT-phase, in terms of the dichotomous multi-domain outcome index (improvements in physical and mental health and social functioning), which has been– and still is – used in the ongoing heroin study, (2) the number of cocaine metabolite-free urine samples during the trial period, (3) the percentage of patients with cocaine-free urine samples for at least 8, 12, and 16 consecutive weeks during the trial period, and (4) treatment retention. | — |
Contacts
Public ContactP. Blanken
Parnassia Addiction Research Centre (PARC), Brijder Addiction Treatment. Monsterseweg 83, PO Box 53002, 2505 AA Den Haag, The Netherlands.
Outcome results
None listed