Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 65

Clonidine to reduce craving in hospitalized people with cocaine or crack use disorder

Official title: Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.

Run by University of Sao Paulo General Hospital · NCT07313371 · Data updated 2026-11-12

This will try clonidine versus clonazepam to see if clonidine lowers craving in people hospitalized for cocaine or crack use disorder.

More Cocaine Use Disorder trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment36 (estimated)
SponsorUniversity of Sao Paulo General Hospital
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedJanuary 28, 2026
Main results expectedJuly 2026
Study endsJuly 2027
Registry record updatedFebruary 24, 2026
Trial IDNCT07313371 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Hospitalized adults at the Instituto Perdizes with DSM-5 cocaine or crack use disorder who voluntarily seek treatment, can swallow pills, and can read and complete study questionnaires are ideal candidates.

Probably not a fit

People with benzodiazepine, opioid, or alcohol use disorders, those who cannot read or complete questionnaires, and non-hospitalized outpatients are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized interventional study in hospitalized adults with DSM-5 cocaine or crack use disorder at the Instituto Perdizes (Hospital das Clínicas, University of São Paulo). Participants are randomized to receive clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours under nursing supervision for the first two weeks, followed by a two-week washout. Vital signs are monitored three times daily to track medication effects such as bradycardia or hypotension. The primary outcome is the change in self-reported cocaine craving from admission to two weeks measured by a visual analog scale.

Why it matters

Potential benefit: If successful, clonidine could offer a simple, low-cost medication option to reduce craving during early inpatient treatment for cocaine or crack use disorder.

How similar studies have gone: Small studies and clinical reports of α2-agonists suggest they can reduce sympathetic symptoms and sometimes craving, but high-quality randomized evidence specifically for cocaine/crack craving is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Clínicas, University of São Paulo Medical School
* DSM-5 criteria for cocaine and/or crack use disorder
* Voluntarily seeking treatment
* Must be able to swallow pills

Exclusion Criteria:

* Inability to read and/or understand the study questionnaires
* benzodiazepine use disorder
* opioid use disorder
* alcohol use disorder

Where it's running

  • Instituto Perdizes
    São Paulo, São Paulo, Brazil
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.