- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631383
Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine (l-THP) With Cocaine Exposure in People With a History of Cocaine Use
September 25, 2019 updated by: MPRC, University of Maryland, Baltimore
This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure in people who have a history of cocaine use.
The subject will be admitted to the Brief Stay Unit (BSU), an inpatient facility at the Maryland Psychiatric Research Center, used for short term drug abuse or clinical trial studies.
The participant will stay for 4 nights and 5 days.
He/she will be randomized to either placebo or l-THP for three days.
On the morning of Day 4, the subject will receive one cocaine dose (40 mg intranasal) and have testing for pharmacokinetic parameters for the following 10 hours.
The subject will stay over one more night and will be discharged the following day.
Approximately 40 subjects will be randomized to enroll the target sample of 30 (N=15 placebo, N=15 l-THP).
In summary, each subject will come for a screening visit(s), then a 5-day, 4-night stay on a secure research unit.
After cocaine administration day, the participant will stay overnight for one more day of observation and to permit substantial l-THP elimination from the body.
The following morning we will get one additional blood specimen for l-THP (Day 5 at 24 hours after last dose (7:30 am); then the participant will be discharged.
A visit with blood collection on Day 6 at 55 hours after last dose (2:30 pm) will be scheduled.
A final follow-up visit will be scheduled 4-7 days after unit discharge to ensure no persisting side effects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Catonsville, Maryland, United States, 21228
- Maryland Psychiatric Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion/Exclusion Criteria:
Inclusion criteria:
- men or non-pregnant/non-nursing women between the ages of 18 and 50 years old
- self reported history of cocaine use (intranasal, IV or smoked) averaging at least twice monthly for at least one month over the prior year
- self- reported use at least one use in the past six months of a cocaine dose equivalent to 40 mg intranasal or 15 mg smoked or intravenous, based on participant's best estimate of weight and/or street price of amount ingested and a
- positive urine drug test for cocaine use at least once in past 1 year
- HIV seronegative
- hepatitis C seronegative
- EKG without clinically significant abnormality
- normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and resting heart rate (60-90 bpm)
- within 20% of ideal body weight, based on BJ Devine formula (1974) (men: 50 + 2.3 kg per inch over 5 feet, women: 45.5 + 2.3 kg per inch over 5 feet)
- ability to adhere to the study restrictions and examination schedule
- Women with reproductive potential must agree to the use of one of the following birth control methods (condom with spermicide, diaphragm, or intrauterine device) during the study and for 2 weeks after study conclusion.
Exclusion criteria:
- participation in any investigational drug trial or clinical drug trial within 45 days before study entry
- donation or loss of greater than one pint of blood within 60 days of study entry
- history of clinically significant adverse reaction or hypersensitivity to any study drug,
- inability to communicate or co-operate with the investigators
- treatment-seeking for cocaine abuse/dependence
- taking any concurrent prescription, over the counter medications, or dietary/nutritional/herbal supplement (such as St. John's wort or grapefruit juice, but not including standard vitamin or mineral supplements) within 14 days prior to initial dosing.
- current clinically significant medical problems that might interfere with safe study participation. This includes pheochromocytoma, untreated hyperthyroidism, dehydration, fever, coronary artery disease, uncorrected congenital heart defect, seizures, electrolyte imbalance, uncontrolled diabetes mellitus, porphyria variegate, superventricular tachycardia, atrial fibrillation, cardiomyopathy, uncontrolled hypertension,.
- Current Axis I psychiatric disorder (except nicotine dependence, cocaine abuse/dependence, or simple phobia). Nicotine does not alter physiologic response to cocaine (Kouri et al 2001)
- Positive for illicit drugs other than cocaine or marijuana on urine drug screen
- Score below 10/12 on the Evaluation to Sign Consent (ESC)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing.
The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily).
Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).
|
Active Comparator: l-THP
|
Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing.
The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily).
Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak heart rate after cocaine administration during treatment with l-THP or placebo.
Time Frame: -10 (min), 5, 20, 35, 50, 65, 80, 95, 2.5 (hr), 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9 10 hr
|
Comparing the peak changes between the two groups accounting for the specified tolerance margin
|
-10 (min), 5, 20, 35, 50, 65, 80, 95, 2.5 (hr), 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9 10 hr
|
Peak blood pressure after cocaine administration during treatment with l-THP or placebo
Time Frame: -10 (min), 5, 20, 35, 50, 65, 80, 95, 2.5 (hr), 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9 10 hr
|
Comparing the peak changes between the two groups accounting for the specified tolerance margin
|
-10 (min), 5, 20, 35, 50, 65, 80, 95, 2.5 (hr), 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9 10 hr
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Peak cocaine plasma concentration after acute cocaine dose during treatment with l-THP
Time Frame: 0,1,20,30,40,50,60,70,80,90, 100, 110 (min), 2 (hr), 2.5, 3, 3.5, 4, 5, 6 hr
|
Cmax and AUC will be compared between the two groups
|
0,1,20,30,40,50,60,70,80,90, 100, 110 (min), 2 (hr), 2.5, 3, 3.5, 4, 5, 6 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Deanna L. Kelly, Pharm.D., BCPP, University of Maryland, College Park
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2012
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 29, 2012
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Antagonists
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Tetrahydropalmatine
Other Study ID Numbers
- HP-00051290
- 1DP1DA031401-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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