Search / Trial NCT00000306

Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Sep 20, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Cocaine Dependence

Description

This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follo...

Gender

All

Eligibility criteria

  • Inclusion Criteria- Subject must:
  • Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
  • Be between 18 and 45 years old
  • Women must agree to use contraception
  • Have an EKG that has been confirmed by a cardiologist
  • Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal
  • Exclusion Criteria- Subject must not:
  • • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent
  • Have any Axis I disorder that is not related to drug use
  • Have current dependence on any psychoactive disorder other than nicotine
  • Be on probation or parole for reasons other than those related to drug charges (ASI)
  • Be pregnant or lactating
  • Have been in any outside treatment in 3 months

Attachments

readout_NCT00000306_2024-06-14.pdf

4.5 MB

NCT00000306_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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