Health TrialsbyHealthPanel

Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder

ConditionsCocaine Use DisorderCrack Abuse or Dependence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Sao Paulo General Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to read and/or understand the study questionnaires

benzodiazepine use disorder

opioid use disorder

alcohol use disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • clonidine

    Drug

    Clonidine 0,1 mg bid

  • clonazepam 0,25 mg

    Drug

    clonazepam 0,25 mg bid

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Scale (VAS)

Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving

Time frame
Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment

Secondary outcomes

1

Adverse Effects

Spontaneous reports

Time frame
from the beginning of the intervention to 90 days after enrollment in the study
2

Blood pressure

Diastolic and systolic pressure in mmHg

Time frame
Three times daily from baseline up to 14 days
3

Heart Rate

Heart rate in beats per minute

Time frame
Three times daily from baseline up to 14 days
4

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)

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
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