A Phase 1 interventional study of Lofexidine and Placebo in Cocaine Related Disorders, sponsored by National Institute on Drug Abuse (NIDA). Terminated at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Treatment
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
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.
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.
Exclusion Criteria:
Drug: Lofexidine
Drug: Placebo
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
0mg
Adverse Event and Cardiovascular Response
Adverse Events will measured during follow-up at weeks 14-21
Time frame: Daily, up to 9 days
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time frame: Daily, up to 9 days
PK of Lofexidine
Time frame: Daily, up to 9 days
Visual Analog Scale (VAS)
Time frame: Daily, up to 9 days
Brief Substance Abuse Craving Scale (BSCA)
Time frame: Daily, up to 9 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)