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Sponsors and Collaborators: |
University of Arkansas National Institute on Drug Abuse (NIDA) |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00593463 |
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 |
---|---|---|
Methadone-Maintained Addiction |
Drug: Naloxone Drug: Saline Drug: Diltiazem Drug: Verapamil Drug: Cycloserine Drug: Gabapentin Drug: Isradipine Drug: Nifedipine Drug: Sugar Pill |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 1 |
Estimated Enrollment: | 40 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Receives 2-4 of the interventions listed
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Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
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2: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
3: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
4: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
5: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
6: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
7: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
8: Experimental
Receives 2-4 of the interventions listed
|
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria
Contact: Julie Owens | 501-686-5801 | OwensJulie@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Alison Oliveto, PhD 501-686-8969 OlivetoAlison@uams.edu | |
Principal Investigator: Alison Oliveto, PhD |
Principal Investigator: | Alison Oliveto, PhD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Carole Hamon ) |
Study ID Numbers: | 57184 |
Study First Received: | January 4, 2008 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00593463 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
drug abuse addiction methadone opioid |
Cycloserine Excitatory Amino Acids Behavior, Addictive Gabapentin Nifedipine Isradipine Naloxone Naphazoline |
Calcium, Dietary Methadone Oxymetazoline Verapamil Guaifenesin Phenylephrine Diltiazem Phenylpropanolamine |
Antimetabolites Respiratory System Agents Anti-Infective Agents Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Narcotic Antagonists Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Reproductive Control Agents Renal Agents |
Membrane Transport Modulators Anti-Bacterial Agents Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Analgesics, Opioid Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Anti-Infective Agents, Urinary Narcotics Cardiovascular Agents Antihypertensive Agents Antimanic Agents |