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

NCT ID: NCT01641159

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-06-30

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Buspirone plus TAU

Buspirone titrated to 60 mg/day for the 15-week active study

Group Type: ACTIVE_COMPARATOR

Buspirone

Intervention Type: DRUG

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.

Placebo plus TAU

Placebo taken daily for the 15-week active study

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

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 Type: DRUG

Other Intervention Names

Buspirone hydrochloride, Buspar; Matched placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Theresa Winhusen

Associate Professor, Department of Psychiatry and Behavioral Neuroscience; CinARC Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Winhusen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati, CTN Ohio Valley Node

Locations

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

Countries

United States

References

Winhusen T, Brady KT, Stitzer M, Woody G, Lindblad R, Kropp F, Brigham G, Liu D, Sparenborg S, Sharma G, Vanveldhuisen P, Adinoff B, Somoza E. Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world. Contemp Clin Trials. 2012 Sep;33(5):993-1002. doi: 10.1016/j.cct.2012.05.003. Epub 2012 May 19.

Reference Type: BACKGROUND

PMID: 22613054 (View on PubMed)

Winhusen TM, Kropp F, Lindblad R, Douaihy A, Haynes L, Hodgkins C, Chartier K, Kampman KM, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, May J, Brigham GS. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. J Clin Psychiatry. 2014 Jul;75(7):757-64. doi: 10.4088/JCP.13m08862.

Reference Type: DERIVED

PMID: 24911028 (View on PubMed)

Other Identifiers

U10DA013732

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTN-0052

Identifier Type: -

Identifier Source: org_study_id