Drug Discrimination in Methadone-Maintained Humans Study 1

Overview[ - collapse ][ - ]

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.
ConditionDrug Dependence
InterventionDrug: Cycloserine
Drug: Diltiazem
Drug: Gabapentin
Drug: Isradipine
Drug: Naloxone
Drug: Nifedipine
Drug: Placebo
Device: Saline
Drug: Verapamil
PhasePhase 1
SponsorUniversity of Arkansas
Responsible PartyUniversity of Arkansas
ClinicalTrials.gov IdentifierNCT00593463
First ReceivedJanuary 4, 2008
Last UpdatedMarch 10, 2011
Last verifiedMarch 2011

Tracking Information[ + expand ][ + ]

First Received DateJanuary 4, 2008
Last Updated DateMarch 10, 2011
Start DateSeptember 2006
Estimated Primary Completion DateMay 2010
Current Primary Outcome MeasuresDrug Discrimination Measure [Time Frame: Every session] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Self-reported effects [Time Frame: Every Session] [Designated as safety issue: No]
  • Vital Signs [Time Frame: Every session] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleDrug Discrimination in Methadone-Maintained Humans Study 1
Official TitleDrug Discrimination in Methadone-Maintained Humans Study 1
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignIntervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
ConditionDrug Dependence
InterventionDrug: Cycloserine
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Other Names:
  • Calan
  • Veralan
Drug: Diltiazem
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Other Names:
CardizemDrug: Gabapentin
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Other Names:
NeurontinDrug: Isradipine
Isradipine: 5, 10 mg oral capsule may possibly be given
Other Names:
DynaCircDrug: Naloxone
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Other Names:
NarcaDrug: Nifedipine
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Other Names:
  • Adalat
  • Procardia
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 Names:
Veralan
Study Arm (s)Experimental: 1
Receives 2-4 of the interventions listed

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment40
Estimated Completion DateMay 2010
Estimated Primary Completion DateMay 2010
Eligibility Criteria
Inclusion Criteria:

1. Must be between the ages of 18-65.

2. 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.

3. 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

4. Subjects must submit a urine sample negative for illicit drugs prior to study entry.

5. Subjects must be able to read and understand English.

Exclusion Criteria:

Exclusion criteria

1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be
determined by history provided by the prospective subject or laboratory evaluation as
outlined below).

2. Current diagnosis of other drug or alcohol physical dependence (other than tobacco).

3. History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)

4. Pregnancy, plans to become pregnant or inadequate birth control.

5. 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.

6. 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.

7. Liver function tests greater than 3 times normal, BUN and Creatinine outside normal
range, or thyroid function tests outside normal range.

8. 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00593463
Other Study ID NumbersR01-DA010017-01
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Arkansas
Study SponsorUniversity of Arkansas
CollaboratorsNot Provided
Investigators Principal Investigator: Alison Oliveto, PhD University of Arkansas
Verification DateMarch 2011

Locations[ + expand ][ + ]

University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205