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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Arkansas |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00733239 |
This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
Condition | Intervention | Phase |
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Opioid Dependence |
Drug: 2-4 of the drugs listed below |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Double Blind (Subject, Investigator), Single Group Assignment |
Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 2 |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Receives 2-4 of the drugs listed under Intervention
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Drug: 2-4 of the drugs listed below
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paula Duke, RN, MA | 501-526-8447 | DukePaulaL@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Alison Oliveto 501-686-8969 olivetoalison@uams.edu |
Principal Investigator: | Alison Oliveto, Ph.D. | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Alison Oliveto, Ph.D./Principal Investigator ) |
Study ID Numbers: | R01-DA010017-02, 104881, 5 R01 DA010017-02 |
Study First Received: | August 11, 2008 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00733239 History of Changes |
Health Authority: | United States: Food and Drug Administration |
methadone opioid dependence opioid |
Antimetabolites Cycloserine Gabapentin Central Nervous System Depressants Disorders of Environmental Origin Narcotics Anti-Infective Agents, Urinary Opioid-Related Disorders Nifedipine Isradipine Naloxone Naphazoline |
Anti-Bacterial Agents Methadone Verapamil Guaifenesin Mental Disorders Diltiazem Substance-Related Disorders Peripheral Nervous System Agents Analgesics Phenylpropanolamine Antitubercular Agents Analgesics, Opioid |
Antimetabolites Anti-Infective Agents Respiratory System Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Renal Agents Opioid-Related Disorders Anti-Bacterial Agents Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders |
Analgesics Analgesics, Opioid Cycloserine Central Nervous System Depressants Anti-Infective Agents, Urinary Narcotics Pharmacologic Actions Antibiotics, Antitubercular Methadone Antitubercular Agents Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents |