Clonidine to reduce craving in hospitalized people with cocaine or crack use disorder
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.
This will try clonidine versus clonazepam to see if clonidine lowers craving in people hospitalized for cocaine or crack use disorder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07313371 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
São Paulo, São Paulo
- Instituto Perdizes — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Dangela Lassi — University of São Paulo General Hospital
- Study coordinator: Dangela Lassi
- Email: dangela.lassi@hc.fm.usp.br
- Phone: +551138032802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.