Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Recurrence; Cocaine-Related Disorders
Intervention: Buspirone; Placebo
Intervention description: 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.; Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
Intervention MeSH terms: Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cocaine; Crack; Buspirone; Relapse Prevention

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. be 18 years of age or older

          2. be able to understand the study, and having understood, provide written informed
             consent in English

          3. 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

          4. have a willingness to comply with all study procedures and medication instructions

          5. 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)

          6. 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:

          1. meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) opioid
             dependence

          2. 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

          3. have a psychiatric disorder requiring continued treatment with a psychotropic
             medication

          4. have a known or suspected hypersensitivity to buspirone

          5. be pregnant or breastfeeding

          6. 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)

          7. 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.

          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.)

          9. be a significant suicidal/homicidal risk