A Stepwise Strategy Utilizing Buprenorphine and Methadone

NCT00310934 | Completed Phase 4

• 1 other identifier: KarolinskaUH Regional 373/03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heroin Dependence

Keywords

heroin dependence; methadone; buprenorphine; contingency management; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Retention in treatment

Secondary Outcomes (2)

• Proportion urine samples free of illicit drugs

• Problem severity as measured by Addiction Severity Index

Interventions

methadone DRUG

buprenorphine / methadone sequence DRUG

Relapse prevention BEHAVIORAL

Contingency management BEHAVIORAL

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Swedish National Drug Policy Coordinator: collaborator
• Region Stockholm: collaborator
• Schering-Plough: collaborator

Study Sites (1)

Dept of Clinical Neuroscience, Karolinska Inst

Stockholm, 14176, Sweden

Location

MeSH Terms

Conditions

Heroin Dependence

Interventions

Methadone; Buprenorphine; Secondary Prevention

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Markus Heilig, MD PhD

  Karolinska Institute, Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: August 1, 2005
• Study Completion: March 1, 2006
• Last Updated: October 24, 2006

Record last verified: 2006-03

Locations

SE (1)