Intervention: Buspirone
Trial phase: Phase 2
ATC code: N05BE01
SMILES: O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Buspirone titrated to 60 mg/day for the 15-week active study

Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
Eligibility criteria:
Inclusion Criteria:

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

Exclusion Criteria:

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