Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2
A Double-Blind, Placebo Controlled Trial of Propranolol and Amantadine for the Treatment of Cocaine Dependent Subjects With Severe Cocaine Withdrawal Symptoms
3 other identifiers
interventional
199
1 country
1
Brief Summary
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Amantadine, a medication that improves muscle control, and propranolol, a medication that lowers blood pressure, may be useful in treating cocaine addiction in individuals with severe cocaine withdrawal symptoms. This study will evaluate the effectiveness of amantadine and propranolol in preventing drug relapse among cocaine addicts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 1999
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 12, 2017
October 1, 2016
5.5 years
September 8, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cocaine abstinence; measured by self-reported Time line follow-back and confirmed with cocaine urine tests.
8 weeks
Study Arms (4)
Propranolol
EXPERIMENTALPropranolol 100mg/day in 3 divided doses
Amantadine
EXPERIMENTALAmantadine 100mg three times daily
Propranolol and Amantadine
EXPERIMENTALPropranolol 100mg/day in 3 divided doses and Amantadine 100mg 3X's daily
Placebo
PLACEBO COMPARATORIdentical Placebo pills
Interventions
Eligibility Criteria
You may qualify if:
- Male and females, 18 to 60 years old.
- Meets DSM-IV diagnosis criteria for cocaine dependence as determined by the Structured Clinical Interview for DSM-IV (SCID)
- Score of at least (\> or =) 22 on the Initial Cocaine Selective Severity Assessment (CSSA)
- Lives within commuting distance of the Treatment Research Center (TRC) and the Penn/VA Center for Studies of Addiction, University of Pennsylvania
- If female, willing to use contraception throughout the study
- Continued use of cocaine during a two week evaluation phase prior to medication treatment as demonstrated by at least 2 new uses of cocaine documented by quantitative urine toxicology screen obtained three times weekly according to new use rules
You may not qualify if:
- Meets DSM-IV/SCID diagnosis criteria for dependence on any drugs other than cocaine, marijuana, or nicotine. Cocaine dependent subjects who identify cocaine dependence as their primary addiction but who also meet criteria for alcohol dependence will be accepted as long as the alcohol dependence is not severe enough to require medications for alcohol detoxification.
- Concomitant treatment with psychotropic medications.
- Patients mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the patient's self-report.
- Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant medication)
- Sensitivity to propranolol or amantadine
- Use of any investigational medication within the past 30 days.
- History of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
- History of chest pain associated with cocaine use which has prompted a visit to a physician.
- Current use of reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines, or anticonvulsants
- Bronchospastic disease
- Hyperthyroidism
- Diabetes mellitus
- Patients with known AIDS or other serious illnesses which may require hospitalization during the study.
- Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control. Acceptable methods of birth control include:
- barrier (diaphragm or condom) with spermicide
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104 6178, United States
Related Publications (1)
Kampman KM, Dackis C, Lynch KG, Pettinati H, Tirado C, Gariti P, Sparkman T, Atzram M, O'Brien CP. A double-blind, placebo-controlled trial of amantadine, propranolol, and their combination for the treatment of cocaine dependence in patients with severe cocaine withdrawal symptoms. Drug Alcohol Depend. 2006 Nov 8;85(2):129-37. doi: 10.1016/j.drugalcdep.2006.04.002. Epub 2006 May 11.
PMID: 16697124RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen M. Pettinati, Ph.D.
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
September 1, 1999
Primary Completion
March 1, 2005
Study Completion
February 1, 2006
Last Updated
January 12, 2017
Record last verified: 2016-10