Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence

Completed · Phase 2 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

The purpose of this study is to evaluate whether or not buspirone is effective in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge.

Key facts

Study ID: NCT01641159
Run by: University of Cincinnati
People needed: 62
Starts: 2012-08-01
Expected to finish: 2013-06-01
Last updated by the study team: 2015-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

be 18 years of age or older
be able to understand the study, and having understood, provide written informed consent in English
meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine, must self-report having used crack cocaine a minimum of four times in the 28 days prior to inpatient/residential admission, and must report that their typical pattern of use is at least once a week
have a willingness to comply with all study procedures and medication instructions
be enrolled in an inpatient/residential program at a participating CTP, scheduled to be in inpatient/residential treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase (i.e., study week 15)
if female and of child bearing potential, agree to use one of the following methods of birth control:
oral contraceptives
contraceptive patch
barrier (diaphragm or condom)
intrauterine contraceptive system
levonorgestrel implant
medroxyprogesterone acetate contraceptive injection
complete abstinence from sexual intercourse
hormonal vaginal contraceptive ring

You may not qualify if…

meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) opioid dependence
have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:
AIDS according to the current CDC criteria for AIDS
liver function tests greater than 3X upper limit of normal
serum creatinine greater than 2 mg/dL
have a psychiatric disorder requiring continued treatment with a psychotropic medication
have a known or suspected hypersensitivity to buspirone
be pregnant or breastfeeding
have used any of the following medications within 14 days of randomization: monoamine oxidase (MAO) inhibitors such as phenelzine (Nardil), selegiline (Eldepryl), isocarboxazid (Marplan), or tranylcypromine (Parnate)
be taking any medications which, in the judgment of the study physician, may produce interactions with buspirone that are sufficiently dangerous so as to exclude the patient from participating in the study. Alternatively, the study physician, in consultation with the patient and his or her physician, may elect to withdraw the patient from the problem medications before randomization. Some of the possible interactions are discussed in section 8.8.
be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
be a significant suicidal/homicidal risk

Where it is running

Gateway Community Services — Jacksonville, Florida, United States
Maryhaven Inc — Columbus, Ohio, United States
Penn Presbyterian — Philadelphia, Pennsylvania, United States
Addiction Medicine Services — Pittsburgh, Pennsylvania, United States
Morris Village/LRADAC — Columbia, South Carolina, United States
Nexus Recovery Services — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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