- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01148992
Interactions Between Intravenous (IV) Cocaine and Lofexidine
January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
California
-
San Francisco, California, United States, 94110
- California Pacific Medical Center Research Institute
-
-
Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
- Be between 18 and 50 years of age, inclusive.
- Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
- Be able to verbalize understanding of the consent form and provide written informed consent.
Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:
- diaphragm and condom by partner
- intrauterine device (that does not contain progesterone) and condom by partner
- sponge and condom by partner
- complete abstinence from sexual intercourse
Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.
Exclusion Criteria:
- Please contact site for more information
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
|
0mg
|
Active Comparator: Lofexidine
|
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event and Cardiovascular Response
Time Frame: Daily, up to 9 days
|
Adverse Events will measured during follow-up at weeks 14-21
|
Daily, up to 9 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time Frame: Daily, up to 9 days
|
Daily, up to 9 days
|
PK of Lofexidine
Time Frame: Daily, up to 9 days
|
Daily, up to 9 days
|
Visual Analog Scale (VAS)
Time Frame: Daily, up to 9 days
|
Daily, up to 9 days
|
Brief Substance Abuse Craving Scale (BSCA)
Time Frame: Daily, up to 9 days
|
Daily, up to 9 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
August 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
June 17, 2010
First Submitted That Met QC Criteria
June 22, 2010
First Posted (Estimate)
June 23, 2010
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Narcotic Antagonists
- Lofexidine
Other Study ID Numbers
- Lofexidine-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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