A Stepwise Strategy Utilizing Buprenorphine and Methadone - Full Text View

Sponsor:	Karolinska University Hospital
Collaborators:	Swedish National Drug Policy Coordinator Stockholm County Council, Sweden Schering-Plough
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00310934

Purpose

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.

Condition	Intervention	Phase
Heroin Dependence	Drug: methadone Drug: buprenorphine / methadone sequence Behavioral: Relapse prevention Behavioral: Contingency management	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Graded Strategy for Pharmacological Treatment of Heroin Dependence

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Retention in treatment

Secondary Outcome Measures:

Proportion urine samples free of illicit drugs
Problem severity as measured by Addiction Severity Index

Estimated Enrollment:	96
Study Start Date:	August 2005
Estimated Study Completion Date:	March 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310934

Locations

Sweden
Dept of Clinical Neuroscience, Karolinska Inst
Stockholm, Sweden, 14176

Sponsors and Collaborators

Karolinska University Hospital

Swedish National Drug Policy Coordinator

Stockholm County Council, Sweden

Schering-Plough

Investigators

Principal Investigator:

Markus Heilig, MD PhD

Karolinska Institute, Stockholm

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00310934 History of Changes
Other Study ID Numbers:	KarolinskaUH Regional 373/03
Study First Received:	April 3, 2006
Last Updated:	October 23, 2006
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:

heroin dependence
methadone
buprenorphine
contingency management
relapse prevention

Additional relevant MeSH terms:

Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012