Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: clonidine, clonazepam 0,25 mg.
- Who it may be relevant to
- Registry conditions: Cocaine Use Disorder, Crack Abuse or Dependence. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.
Overview
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.
Interventions
- Drug clonidine
Clonidine 0,1 mg bid - Drug clonazepam 0,25 mg
clonazepam 0,25 mg bid
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Instituto Perdizes — São Paulo
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. PMID 35448887
Identifiers
NCT: NCT07313371 · 86251324.2.0000.0068