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

NCT01641159 | Completed Phase 2 Results DMC

• 2 other identifiers: CTN-0052U10DA013732
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

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.

Conditions

Cocaine Dependence

Keywords

Cocaine; Crack; Buspirone; Relapse Prevention

Outcome Measures

Primary Outcomes (1)

• Maximum Days of Continuous Cocaine Abstinence

  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.

  study week 16

Secondary Outcomes (1)

• Cocaine-use Days

  study week 16

Study Arms (2)

Buspirone plus TAU

ACTIVE COMPARATOR

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

Drug: Buspirone

Placebo plus TAU

PLACEBO COMPARATOR

Placebo taken daily for the 15-week active study

Drug: Placebo

Interventions

Buspirone 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.

Also known as: Buspirone hydrochloride, Buspar

Buspirone plus TAU

Placebo 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.

Also known as: Matched placebo

Placebo plus TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (6)

Gateway Community Services

Jacksonville, Florida, 32204, United States

Location

Maryhaven Inc

Columbus, Ohio, 43207, United States

Location

Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Addiction Medicine Services

Pittsburgh, Pennsylvania, 15213, United States

Location

Morris Village/LRADAC

Columbia, South Carolina, 29203, United States

Location

Nexus Recovery Services

Dallas, Texas, 75228, United States

Location

Related Publications (2)

• 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.

  PMID: 22613054 BACKGROUND

• 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.

  PMID: 24911028 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Theresa Winhusen
• Organization: University of Cincinnati College of Medicine; Department of Psychiatry

winhust@ucmail.uc.edu

513-585-8227

Study Officials

• Theresa Winhusen, PhD

  University of Cincinnati, CTN Ohio Valley Node

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry and Behavioral Neuroscience; CinARC Director

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 16, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 7, 2015
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

US (6)