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Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse

NCT05569031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-10-06

No results posted yet for this study

Summary

Tramadol abuse is a public health problem in Egypt. There are no approved medications for treatment of withdrawal symptoms or prevention of relapse in patients with tramadol abuse. The objective of this study was to compare the efficacy of venlafaxine and lofixidine in treating the withdrawal symptoms and to compare between venlafaxine and naltrexone in relapse prevention of tramadol abuse. Patients with tramadol abuse will be divided randomly to use venlafaxine or lofixidine after discontinuation of tramadol. The efficacy will be measured by the Clinical Opiate Withdrawal Scale. The medications will be used for 10 days after discontinuation of tramadol. After the detoxification stage, patients who used venlafaxine will continue to use it while patients who used lofixidine will use naltrexone during the relapse prevention phase (2 months).

Conditions

  • Opiate Withdrawal Syndrome

Interventions

DRUG

Venlafaxine

patients with tramadol abuse will use venlafaxine for 10 days.

DRUG

Lofexidine

patients with tramadol abuse will use lofixidine for 10 days.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-15
Completion
2022-06-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05569031 on ClinicalTrials.gov