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Cocaine DependencePhase 2BRACNCT01641159

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

A Phase 2 study testing Buspirone in people with Cocaine Dependence, run by University of Cincinnati at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cocaine Dependence
What is being tested?
Buspirone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
6 sitesUnited States
Study dates
Aug 2012to Jun 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Morris Village/LRADAC

    Columbia, South Carolina, 29203

  • Maryhaven Inc

    Columbus, Ohio, 43207

  • Nexus Recovery Services

    Dallas, Texas, 75228

  • Gateway Community Services

    Jacksonville, Florida, 32204

  • Penn Presbyterian

    Philadelphia, Pennsylvania, 19104

  • Addiction Medicine Services

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)

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.

Read the 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.

Being tested
Buspirone, Placebo
Keywords
Cocaine, Crack, Buspirone, Relapse Prevention
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BuspironeDrug

    Also called Buspirone hydrochloride, Buspar

    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.

  • PlaceboDrug

    Also called Matched 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.

Study groups in NCT01641159
Study groupRoleWhat they receive
Buspirone plus TAUActive comparatorBuspirone titrated to 60 mg/day for the 15-week active study
Receives: Drug: Buspirone
Placebo plus TAUPlacebo comparatorPlacebo taken daily for the 15-week active study
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: study week 16

Secondary outcomes (1)

  1. Cocaine-use Days

    Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation

    Measured: study week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01641159
Sponsor's protocol ID
CTN-0052
Other IDs
U10DA013732
Acronym
BRAC
Status last verified
Dec 2014
First submitted
10 Jul 2012
Last updated
7 Jan 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22613054

  • 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.

    PubMed 24911028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Buspirone in people with Cocaine Dependence, run by University of Cincinnati at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Days of Continuous Cocaine Abstinence (time frame: study week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01641159, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015.

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