Drug Discrimination in Methadone-Maintained Humans Study 1 (OMDD1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00593463|
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : March 11, 2011
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Drug Dependence||Drug: Cycloserine Drug: Diltiazem Drug: Gabapentin Drug: Isradipine Drug: Naloxone Drug: Nifedipine Drug: Placebo Device: Saline Drug: Verapamil||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Drug Discrimination in Methadone-Maintained Humans Study 1|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Receives 2-4 of the interventions listed
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Other Name: Cardizem
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Other Name: Neurontin
Isradipine: 5, 10 mg oral capsule may possibly be given
Other Name: DynaCirc
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Other Name: Narca
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
Other Name: Veralan
- Drug Discrimination Measure [ Time Frame: Every session ]
- Self-reported effects [ Time Frame: Every Session ]
- Vital Signs [ Time Frame: Every session ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must be between the ages of 18-65.
- Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the CATAR Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
- Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as < 3 missed methadone medications and missed < 3 group or <3 individual therapy sessions in the two months prior to study participation
- Subjects must submit a urine sample negative for illicit drugs prior to study entry.
- Subjects must be able to read and understand English.
- Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
- Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
- Pregnancy, plans to become pregnant or inadequate birth control.
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested.
- History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
- Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged with QTc interval (>420 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593463
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Alison Oliveto, PhD||University of Arkansas|
|Responsible Party:||Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences|
|Other Study ID Numbers:||
R01DA010017-01 ( U.S. NIH Grant/Contract )
R01DA010017 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
|First Posted:||January 15, 2008 Key Record Dates|
|Last Update Posted:||March 11, 2011|
|Last Verified:||March 2011|
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents