NCT05569031

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

October 3, 2022

Last Update Submit

October 5, 2022

Conditions

Opiate Withdrawal Syndrome

Keywords

tramadol abuse; withdrawal; lofixidine; venlaaxine

Outcome Measures

Primary Outcomes (1)

  • detoxification stage

    the efficacy was measured by decrease in the score of the "Clinical Opiate Withdrawal Scale (COWS). Increase in the score means worsening and score decrease means improvement. We compared the mean + SD for all groups. COWS Score: 5- 12 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

    10 days

Secondary Outcomes (1)

  • Relapse prevention

    2 months

Study Arms (2)

venlafaxidine

ACTIVE COMPARATOR

venlafaxine 75-225 mg per day.

Drug: Venlafaxine

Lofixidine

ACTIVE COMPARATOR

Lofixidine 1.6 to 2.4 per day.

Drug: Lofexidine

Interventions

VenlafaxineDRUG

patients with tramadol abuse will use venlafaxine for 10 days.

venlafaxidine
LofexidineDRUG

patients with tramadol abuse will use lofixidine for 10 days.

Lofixidine

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients should meet DSM-IV criteria for opioid use disorder.
  • Both genders will be included.
  • Age will be above 18 years.
  • All socioeconomic classes and educational levels will be included.

You may not qualify if:

  • Age: 18 years or below.
  • Presence of mental retardation, dementia or delirium. .
  • Pregnancy or lactation.
  • Known history of allergy, adverse effects or sensitivity to the study medication.
  • Unstable psychiatric or medical condition.
  • Immediate suicide risk.
  • Regular use of psychoactive drugs or dependence on substances other than opioids, nicotine, or caffeine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (1)

  • Bassiony MM, Abdelfattah NR, Elshabrawy A, Adly MM. A comparative study of the efficacy of venlafaxine and naltrexone for relapse prevention in patients with opioid use disorder attributed to tramadol. Int Clin Psychopharmacol. 2024 Nov 1;39(6):341-349. doi: 10.1097/YIC.0000000000000487. Epub 2023 Sep 20.

    PMID: 37729663DERIVED

MeSH Terms

Interventions

Venlafaxine Hydrochloridelofexidine

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 6, 2022

Study Start

January 1, 2019

Primary Completion

December 15, 2021

Study Completion

June 15, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)