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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: | NCT00733239 |
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Receives 2-4 of the drugs listed under Intervention
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion 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, Ph.D. | University of Arkansas |
More Information
| 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, DPMCDA |
| Study First Received: | August 11, 2008 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00733239 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
methadone opioid dependence opioid |
|
Antimetabolites Anti-Infective Agents Respiratory System Agents Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Gabapentin Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Disorders of Environmental Origin Excitatory Amino Acid Agents Reproductive Control Agents |
Opioid-Related Disorders Renal Agents Nifedipine Isradipine Membrane Transport Modulators Anti-Bacterial Agents Tocolytic Agents Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Analgesics Analgesics, Opioid Excitatory Amino Acid Antagonists Cycloserine |