Interactions Between Intravenous (IV) Cocaine and Lofexidine
NCT ID: NCT01148992
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2010-08-31
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
NCT02393599
Assessment of Potential Interactions Between Cocaine and Tolcapone - 1
NCT00033059
Treatment of Cocaine Dependence With Lisdexamfetamine
NCT00958282
Infusion Laboratory: Protocol 5 (Flupenthixol) - 14
NCT00000349
Ph1 Lobeline Interaction Study - 1
NCT00439504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lofexidine
Lofexidine
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
Placebo
Placebo
0mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lofexidine
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
Placebo
0mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
California Pacific Medical Center Research Institute
San Francisco, California, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lofexidine-0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.