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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Collaborator: |
University of Arkansas |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00593463 |
Purpose
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 |
|---|---|---|
|
Drug Dependence |
Drug: Cycloserine Drug: Diltiazem Drug: Gabapentin Drug: Isradipine Drug: Naloxone Drug: Nifedipine Drug: Placebo Device: Saline Drug: Verapamil |
Phase I |
| Study Type: | Interventional |
| Study Design: | Double Blind (Subject, Investigator), Single Group Assignment |
| Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 1 |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Receives 2-4 of the interventions listed
|
Drug: Cycloserine
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Drug: Diltiazem
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Drug: Gabapentin
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Drug: Isradipine
Isradipine: 5, 10 mg oral capsule may possibly be given
Drug: Naloxone
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Drug: Nifedipine
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Drug: Placebo
Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given
Device: Saline
Saline: I.M. injection may possibly be given
Drug: Verapamil
Verapamil: 30, 60, 120 mg oral capsule may possibly be given
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
Contacts and Locations| Contact: Paula Duke, RN, MA | 501-526-8447 | dukepaulac@uams.edu |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Alison Oliveto, PhD 501-526-8441 OlivetoAlison@uams.edu | |
| Principal Investigator: Alison Oliveto, PhD | |
| Principal Investigator: | Alison Oliveto, PhD | University of Arkansas |
More Information
| Responsible Party: | University of Arkansas for Medical Sciences ( Alison Oliveto, Ph.D./Principal Investigator ) |
| Study ID Numbers: | R01-DA010017-01, 57184, R01DA010017, DPMC |
| Study First Received: | January 4, 2008 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00593463 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
opioid dependence methadone opioid |
|
Anti-Infective Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Calcium Channel Blockers Excitatory Amino Acid Agents Renal Agents Isradipine Membrane Transport Modulators Therapeutic Uses Substance-Related Disorders Tranquilizing Agents Anti-Infective Agents, Urinary |
Narcotics Antihypertensive Agents Verapamil Diltiazem Anti-Anxiety Agents Antitubercular Agents Antitussive Agents Antimetabolites Respiratory System Agents Vasodilator Agents Narcotic Antagonists Psychotropic Drugs Disorders of Environmental Origin Antiparkinson Agents Reproductive Control Agents |