Overview

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

Status:
Completed

Trial end date:
2022-06-15

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zagazig University

Treatments:

Lofexidine
Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

Inclusion criteria:

1. All patients should meet DSM-IV criteria for opioid use disorder.

2. Both genders will be included.

3. Age will be above 18 years.

4. All socioeconomic classes and educational levels will be included.

Exclusion criteria:

1. Age: 18 years or below.

2. Presence of mental retardation, dementia or delirium. .

3. Pregnancy or lactation.

4. Known history of allergy, adverse effects or sensitivity to the study medication.

5. Unstable psychiatric or medical condition.

6. Immediate suicide risk.

7. Regular use of psychoactive drugs or dependence on substances other than opioids,
nicotine, or caffeine.