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Clinical Trials/NCT05256485
NCT05256485
Completed
Not Applicable

Comparing the Effect of Cognitive Behavioral Therapy, Mindfulness Based Relapse Prevention and Twelve-step Therapy in Patients With Opioid Craving

Sara Harby1 site in 1 country45 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Addiction Opiate
Sponsor
Sara Harby
Enrollment
45
Locations
1
Primary Endpoint
opioid craving scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.

Detailed Description

In this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria. Then, three groups of 20 were randomly selected and placed in three intervention groups, group one received CBT, group two received MBRP, and group three received twelve-step therapy. The subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly. All participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
October 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Sara Harby
Responsible Party
Sponsor Investigator
Principal Investigator

Sara Harby

assistant lecturer

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Age: 15-50 years.
  • Male gender.
  • Patients meet DSM-5(3) criteria of opioid abuse.
  • Had completed detoxification in a treatment center.
  • Willing to give consent they will be randomly assigned to either CBT, MBRP, or twelve-step treatment group.
  • Patients have dual diagnoses.
  • Patients have poly-substance use disorder.

Exclusion Criteria

  • Participants with significant cognitive disorder.
  • Participants with suicidal thoughts.
  • Participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders.
  • Participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response.
  • Participants relapsed to drug abuse during therapy.

Outcomes

Primary Outcomes

opioid craving scale

Time Frame: 5 minutes

A visual analog scale, a modification of the Cocaine Craving Scale, is a 3-item scale used to measure the opioid craving and each item is ranging from 0 to 10 (0 means no craving at all and 10 means severe craving).

Secondary Outcomes

  • The Obsessive-Compulsive Drug use Scale(15 minutes)
  • The desire for a drug questionnaire(15 minutes)

Study Sites (1)

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