A Stepwise Strategy Utilizing Buprenorphine and Methadone

Karolinska University Hospital

Status and phase

Completed

Phase 4

Conditions

Heroin Dependence

Treatments

Drug: buprenorphine / methadone sequence

Behavioral: Relapse prevention

Drug: methadone

Behavioral: Contingency management

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00310934

KarolinskaUH Regional 373/03

Details and patient eligibility

About

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

Full description

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Heroin dependence according to DSM IV > 1year
Age > 20 years
Acceptance of the stated treatment principles.

Exclusion criteria

Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
Other clinically significant psychiatric illness unless stable under treatment
Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
Other clinically significant medical condition unless stable under treatment
Treatment with anti-seizure drugs or disulfiram
Pregnancy or intent to become pregnant within the next year
Ongoing nursing
Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.