Cocaine Use DisorderPhase 4NCT07313371
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
A Phase 4 study testing clonidine and clonazepam 0,25 mg in people with Cocaine Use Disorder and Crack Abuse or Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder, Crack Abuse or Dependence
- What is being tested?
- clonidine and clonazepam 0,25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jan 2026to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to read and/or understand the study questionnaires
- benzodiazepine use disorder
- opioid use disorder
- alcohol use disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Perdizes
São Paulo, São Paulo, 05021-001
DANGELA LASSI, +551138032802, dangela.lassi@hc.fm.usp.br
About this study
Official title: Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.
This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam.
Read the detailed description
Patients included will be administered clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours for the first 2 weeks of treatment, followed by a washout for the final 2 weeks. The medication will be administered under the supervision of a member of the nursing staff. Patients will be monitored with vital signs three times a day to track changes that may be caused by the medication, such as reduced heart rate and hypotension. The primary outcome measure will be the change in cocaine craving at admission and two weeks after the start of treatment, using the visual analog scale.
- Conditions
- Cocaine Use Disorder, Crack Abuse or Dependence
- Being tested
- clonidine, clonazepam 0,25 mg
- Keywords
- crack, cocaine, craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidineDrug
Clonidine 0,1 mg bid
clonazepam 0,25 mgDrug
clonazepam 0,25 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Clonazepam 0,25 mg Receives: Drug: clonazepam 0,25 mg |
| Intervention | Experimental | Clonidine 0,1 mg Receives: Drug: clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving
Measured: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment
Secondary outcomes (6)
Adverse Effects
Spontaneous reports
Measured: from the beginning of the intervention to 90 days after enrollment in the study
Blood pressure
Diastolic and systolic pressure in mmHg
Measured: Three times daily from baseline up to 14 days
Heart Rate
Heart rate in beats per minute
Measured: Three times daily from baseline up to 14 days
Cinical Global Impression - Severity of Illness (CGI-S)
The Clinical Global Impression - Severity of Illness (CGI-S) is a brief, clinician-rated scale used to assess the current severity of a patient's mental illness at the time of assessment, ranging from 1 (1 Normal, not at all ill) to 7 (Among the most extremely ill patients)
Measured: At baseline
Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) scale is a single-item, clinician-rated assessment tool used to measure the change in a patient's overall clinical condition since the baseline, ranging from 1 (very much improved) to 7 (Very much worse)
Measured: Will be assessed after 1 and 2 weeks from baseline
Crack/Cocaine Use
The Timeline Followback (TFLB) will be used to measure the patient's average daily drug use in standardized units (e.g. Units, grams, or rocks of cocaine/crack)
Measured: 30, 60 and 90 days after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start28 Jan 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dângela Layne Silva Lassi, University of Sao Paulo General Hospital
- Investigators
- Dangela Lassi, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313371
- Sponsor's protocol ID
- 86251324.2.0000.0068
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roque Bravo R, Faria AC, Brito-da-Costa AM, Carmo H, Mladenka P, Dias da Silva D, Remiao F, On Behalf Of The Oemonom Researchers. Cocaine: An Updated Overview on Chemistry, Detection, Biokinetics, and Pharmacotoxicological Aspects including Abuse Pattern. Toxins (Basel). 2022 Apr 13;14(4):278. doi: 10.3390/toxins14040278.
PubMed 35448887
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07313371
- Acronym / sponsor ID
- 86251324.2.0000.0068
- Conditions
- Cocaine Use Disorder, Crack Abuse or Dependence
- Keywords
- crack, cocaine, craving
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam.
Detailed description
Patients included will be administered clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours for the first 2 weeks of treatment, followed by a washout for the final 2 weeks. The medication will be administered under the supervision of a member of the nursing staff. Patients will be monitored with vital signs three times a day to track changes that may be caused by the medication, such as reduced heart rate and hypotension. The primary outcome measure will be the change in cocaine craving at admission and two weeks after the start of treatment, using the visual analog scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: clonazepam 0,25 mgClonazepam 0,25 mg |
| Intervention | Experimental | Drug: clonidineClonidine 0,1 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to read and/or understand the study questionnaires
- benzodiazepine use disorder
- opioid use disorder
- alcohol use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonidineClonidine 0,1 mg bid | Drug | Intervention |
| clonazepam 0,25 mgclonazepam 0,25 mg bid | Drug | Control |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment
Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving
6 secondary outcomes
Adverse Effects
Time frame: from the beginning of the intervention to 90 days after enrollment in the study
Blood pressure
Time frame: Three times daily from baseline up to 14 days
Heart Rate
Time frame: Three times daily from baseline up to 14 days
Cinical Global Impression - Severity of Illness (CGI-S)
Time frame: At baseline
Clinical Global Impression - Improvement (CGI-I)
Time frame: Will be assessed after 1 and 2 weeks from baseline
Crack/Cocaine Use
Time frame: 30, 60 and 90 days after the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 35448887Roque Bravo R, Faria AC, Brito-da-Costa AM, Carmo H, Mladenka P, Dias da Silva D, Remiao F, On Behalf Of The Oemonom Researchers. Cocaine: An Updated Overview on Chemistry, Detection, Biokinetics, and Pharmacotoxicological Aspects including Abuse Pattern. Toxins (Basel). 2022 Apr 13;14(4):278. doi: 10.3390/toxins14040278.
- United Nations Office on Drugs and Crime. Treatment of Stimulant Use Disorders: Current Practices and Promising Perspectives.Link provided by the sponsor.
- Drug Misuse and Addiction. National Institute on Drug Abuse websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dangela Lassi principal investigator
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing clonidine and clonazepam 0,25 mg in people with Cocaine Use Disorder and Crack Abuse or Dependence, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dangela Lassi (+551138032802, dangela.lassi@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment). 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 NCT07313371, which also lists 1 linked publication.
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 24 Feb 2026.