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

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Placebo; Drug: Buspirone

• Registration Number: NCT01641159
• Lead Sponsor: University of Cincinnati

Brief 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.

Detailed Description

The primary objective is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.

Study Timeline

• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-16
• Study Start: 2012-08
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-12
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-09
• Results First Posted: 2014-12-17
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus TAU	Placebo	Placebo taken daily for the 15-week active study
Buspirone plus TAU	Buspirone	Buspirone titrated to 60 mg/day for the 15-week active study

Primary Outcome Measures

Name	Time	Method
Maximum Days of Continuous Cocaine Abstinence	study week 16	The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.

Secondary Outcome Measures

Name	Time	Method
Cocaine-use Days	study week 16	Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation

Trial Locations

Locations (6)

Maryhaven Inc; 🇺🇸 Columbus, Ohio, United States

Penn Presbyterian; 🇺🇸 Philadelphia, Pennsylvania, United States

Addiction Medicine Services; 🇺🇸 Pittsburgh, Pennsylvania, United States

Nexus Recovery Services; 🇺🇸 Dallas, Texas, United States

Morris Village/LRADAC; 🇺🇸 Columbia, South Carolina, United States

Gateway Community Services; 🇺🇸 Jacksonville, Florida, United States