Drug Discrimination in Methadone-Maintained Humans Study 3 (OMDD3)
This study has been completed.
Sponsor:
University of Arkansas
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01068847
First received: February 12, 2010
Last updated: March 6, 2013
Last verified: March 2013
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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 participant'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 participant will receive 2-4 of the listed interventions.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug Dependence |
Drug: 2-4 of the drugs listed below |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 3 |
Resource links provided by NLM:
Drug Information available for:
Cycloserine
Methadone
Verapamil hydrochloride
Naloxone hydrochloride
Methadone hydrochloride
Nifedipine
Diltiazem hydrochloride
Diltiazem
Tizanidine
Tizanidine hydrochloride
Diltiazem malate
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- Drug Discrimination Performance [ Time Frame: Every Session ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Self-Report Ratings [ Time Frame: Every Session ] [ Designated as safety issue: No ]
- Vital Signs [ Time Frame: Every session ] [ Designated as safety issue: Yes ]
- ECG [ Time Frame: Test Sessions ] [ Designated as safety issue: Yes ]
| Enrollment: | 9 |
| Study Start Date: | February 2010 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Receives 2-4 of the drugs listed under Intervention
|
Drug: 2-4 of the drugs listed below
Cycloserine: 500, 675, 750 mg oral capsules may possibly given. Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given. Nifedipine: 10, 20 mg oral capsules may possibly be given. Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given. Saline: I.M. injection may possibly be given. Tizanidine: 4, 8, 12 mg oral capsules may possibly be given. Verapamil: 30, 60, 120 mg oral capsules may possibly be given.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 and <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.
Exclusion Criteria:
- Unstable medical condition (e.g., major, unstable cardiovascular, renal, endocrine or hepatic disease) or stable medical condition requiring treatment that would interact with study medications (e.g., controlled hypertension on an antihypertensive) or ability to participate in study sessions, (e.g.,chronic back pain that would preclude being able to sit for long periods, etc), to be determined by history provided by the prospective subject or laboratory evaluation and physical examination as outlined below. These would be determined by the study physician alone or in consultation with the PI.
- Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar) or current psychiatric disorder that requires medication (e.g., current major depression).
- Pregnancy, plans to become pregnant or inadequate birth control (adequate birth control includes an IUD, condoms, birth control pills, etc). Male participants are encouraged to use condoms because little has been studied on the effects of these drugs on the male reproductive system.
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug (antidepressants, anxiolytics, antipsychotics and anticonvulsants that may also be used for mood stabilization or sleep disruption) or drug (e.g., ciprofloxacin, fluvoxamine) that would have major interaction with drugs to be tested.
- Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- A supine or semi-recumbent blood pressure of 100/65mmHg, a seated blood pressure of 90/60mmHg, or orthostatic change of >20mmHg systolic or >10mmHg diastolic on standing or heart rate less than 60 beats/min.
- EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 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.
- Participants who become arrested and/or incarcerated will not be allowed to continue to participate.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068847
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Alison Oliveto, Ph.D. | University of Arkansas |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01068847 History of Changes |
| Other Study ID Numbers: | R01-DA010017-03, R01DA010017-03, 110528, R01DA010017, DPMC |
| Study First Received: | February 12, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
Opioid dependence methadone opioid |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders Verapamil Nifedipine Cycloserine Methadone Tizanidine Naloxone Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action 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 Physiological Effects of Drugs Central Nervous System Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013