A Stepwise Strategy Utilizing Buprenorphine and Methadone - Full Text View

Sponsors and Collaborators:	Karolinska University Hospital Swedish National Drug Policy Coordinator Stockholm County 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

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Graded Strategy for Pharmacological Treatment of Heroin Dependence

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

Schering-Plough

Investigators

Principal Investigator:

Markus Heilig, MD PhD

Karolinska Institute, Stockholm

More Information

No publications provided

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

Keywords provided by Karolinska University Hospital:

heroin dependence
methadone
buprenorphine
contingency management
relapse prevention

Study placed in the following topic categories:

Heroin Dependence
Heroin
Narcotic Antagonists
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Naphazoline
Methadone

Buprenorphine
Guaifenesin
Mental Disorders
Substance-Related Disorders
Phenylpropanolamine
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Respiratory System Agents
Heroin Dependence
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Methadone

Buprenorphine
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009