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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | January 28, 2026 |
| Main results expected | July 2026 |
| Study ends | July 2027 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07313371 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
- Principal investigator: Dangela Lassi — University of São Paulo General Hospital
- Study coordinator: Dangela Lassi
- Email: dangela.lassi@hc.fm.usp.br
- Phone: +551138032802
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HD-tDCS during CBT for Cocaine Use Disorder
This study tests whether adding high-definition transcranial direct current stimulation to cognitive behavioral therapy helps adults with cocaine use disorder see if CBT works better.
-
Imaging Brain Mitochondrial Complex-I in Cocaine Use Disorder
This study uses a PET scan with [F-18]BCPP-EF to see how mitochondrial Complex-I activity in the brain differs between people with cocaine use disorder and healthy controls.
-
Mild electrical brain stimulation (tDCS) with cognitive training to reduce cocaine cravings.
This trial will test whether brief sessions of mild electrical brain stimulation (tDCS) combined with cognitive reappraisal training can lower craving in adults receiving inpatient treatment for cocaine use disorder.
-
Semaglutide plus cognitive behavioral therapy for cocaine use disorder
This trial will test whether adding semaglutide (a GLP-1 medication) to cognitive behavioral therapy helps adults with cocaine use disorder reduce craving and use.
-
How cocaine use and stopping affects sleep and daily rhythms
This study tries to see how cocaine use and stopping change sleep and circadian rhythms in adults entering supervised inpatient detoxification.
-
Cue-reactivity incubation and cognitive reappraisal in cocaine use disorder
This project will see if practicing cognitive reappraisal reduces cue-triggered brain responses and cravings in people with cocaine use disorder who are early in abstinence.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.