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| Sponsor: | University of Arkansas |
|---|---|
| Information provided by: | University of Arkansas |
| 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: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 1 |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Receives 2-4 of the interventions listed
|
Drug: Cycloserine
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Other Names:
Drug: Diltiazem
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Other Name: Cardizem
Drug: Gabapentin
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Other Name: Neurontin
Drug: Isradipine
Isradipine: 5, 10 mg oral capsule may possibly be given
Other Name: DynaCirc
Drug: Naloxone
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Other Name: Narca
Drug: Nifedipine
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Other Names:
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
Other Name: Veralan
|
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| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Principal Investigator: | Alison Oliveto, PhD | University of Arkansas |
More Information
| Responsible Party: | Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00593463 History of Changes |
| Other Study ID Numbers: | R01-DA010017-01, 57184, R01DA010017, DPMC |
| Study First Received: | January 4, 2008 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
opioid dependence methadone opioid |
|
Substance-Related Disorders Mental Disorders Diltiazem Verapamil Nifedipine Gabapentin Isradipine Cycloserine Methadone Naloxone Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents |
Therapeutic Uses Antihypertensive Agents Vasodilator Agents Anti-Arrhythmia Agents Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |