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Cocaine-Related DisordersPhase 2NCT00158132

Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2

A Phase 2 study testing Propranolol and Amantadine in people with Cocaine-Related Disorders, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cocaine-Related Disorders
What is being tested?
Propranolol and Amantadine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
199 participants
Where
1 siteUnited States
Study dates
Sep 1999to Feb 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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
  • intrauterine progesterone contraceptive system
  • levonorgestrel implant
  • medroxyprogesterone acetate contraceptive injection
  • oral contraceptives.
  • Patients with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
  • Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <5 x ULN are acceptable). A complete list of exclusionary lab results are included in the appendix 1

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104 6178

Other trials in United States

About this study

Official title: A Double-Blind, Placebo Controlled Trial of Propranolol and Amantadine for the Treatment of Cocaine Dependent Subjects With Severe Cocaine Withdrawal Symptoms

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.

Read the detailed description

Cocaine withdrawal symptoms are a major contributing factor for why outpatient cocaine dependence treatment programs often fail. Individuals with severe cocaine withdrawal symptoms often experience anxiety, shaking, and muscle pain. Amantadine is a medication currently used to improve muscle control, reduce shaking, and lessen stiffness. Therefore, it may help reduce the muscle pain that some cocaine addicts experience. By enhancing activity of the brain chemical dopamine, amantadine may also reduce other symptoms associated with cocaine withdrawal. Propranolol is a medication currently used to treat high blood pressure and irregular heart rhythms. It may reduce anxiety and lessen cocaine cravings in individuals addicted to cocaine. The purpose of this study is to evaluate the effectiveness of amantadine and propranolol, alone and in combination, for treating cocaine addicts with severe cocaine withdrawal symptoms.

A 2-week baseline evaluation period will be followed by an 8-week treatment phase. During the baseline evaluation, cocaine use will be measured with urine tests, three times each week. Only participants who are experiencing severe withdrawal symptoms and who use cocaine at least twice during the first 2 weeks will continue in the study. Eligible individuals will then be randomly assigned to receive amantadine alone, propranolol alone, a combination of amantadine and propranolol, or placebo. Treatments will begin at Week 3 and study visits will occur three times each week. Cocaine levels will be monitored throughout the study with urine tests.

Being tested
Propranolol, Amantadine, Placebo
Keywords
cocaine
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropranololDrug

    Propranolol 100mg/day in 3 divided doses

  • AmantadineDrug

    Amantadine 100mg three times daily

  • PlaceboDrug

    Placebo pills

Study groups in NCT00158132
Study groupRoleWhat they receive
PropranololExperimentalPropranolol 100mg/day in 3 divided doses
Receives: Drug: Propranolol
AmantadineExperimentalAmantadine 100mg three times daily
Receives: Drug: Amantadine
Propranolol and AmantadineExperimentalPropranolol 100mg/day in 3 divided doses and Amantadine 100mg 3X's daily
Receives: Drug: Propranolol; Drug: Amantadine
PlaceboPlacebo comparatorIdentical Placebo pills
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cocaine abstinence; measured by self-reported Time line follow-back and confirmed with cocaine urine tests.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startSep 1999
  3. Primary completionMar 2005
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00158132
Sponsor's protocol ID
NIDA-12756-2
Other IDs
P50DA012756-02, DPMC
Status last verified
Oct 2016
First submitted
8 Sep 2005
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16697124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol and Amantadine in people with Cocaine-Related Disorders, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cocaine abstinence; measured by self-reported Time line follow-back and confirmed with cocaine urine tests. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00158132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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