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Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder

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ClinicalTrials.gov Identifier: NCT05593796
Recruitment Status : Not yet recruiting
First Posted : October 25, 2022
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Ahmad Tharwat Ahmad, Assiut University

Study Description
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Brief Summary:
The efficacy of cognitive behavioral therapy(CBT) in treatment of methamphetamine use disorder

Condition or disease Intervention/treatment Phase
Methamphetamine Abuse Behavioral: cognitive behavioral therapy Not Applicable

Detailed Description:

Methamphetamine (MA) use is a serious public health concern in many countries and is second to cannabis as the most widely abused illicit drug in the world.

Over the past few years; there is an alarming increase in crystal methamphetamine (Shabu) abuse in the Egyptian market and The Egyptian government is annoyed from this issue because youth within the age of productivity were targeted.

Regular methamphetamine use can be associated with a range of psychiatric symptoms, particularly psychosis, anxiety, and depression.

No FDA approved pharmacological treatments are available for Meth addiction up till now and despite great advances achieved in understanding the neurobiology of drug addiction, the therapeutic options are severely limited . Consequently, the only available treatment at present is psychosocial intervention.

The effectiveness of CBT for other substance-use disorders (e.g. alcohol-, opioid- and cocaine-use disorders) has been well documented and as such this basic treatment approach has been applied to amphetamine-type stimulant (ATS)-use disorder .

Currently, there is not enough evidence to establish the efficacy of CBT for amphetamine -type stimulant( ATS) -use disorders because of a paucity of high-quality research in this area.

The present study will examine the efficacy of Cognitive behavioral therapy in reducing methamphetamine use in comparison to medical treatment usually taken in methamphetamine use disorder

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In phase 0:

. These patients will undergo toxicological and psychiatric assessment and will be screened using the inclusion and exclusion criteria.

phase 1:

treatment-as-usual (TAU)- Group offered usual treatment include detoxification, medical care. Clinician-delivered CBT-Group offered 12 weekly, individual sessions of manual-guided CBT (15) delivered by trained clinician .

phase2: a follow-up at 3-month post treatment phase without treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder
Estimated Study Start Date : April 1, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: treatment-as-usual (TAU) Behavioral: cognitive behavioral therapy
12 weekly, individual sessions of manual-guided CBT delivered by trained clinician .
Active Comparator: Clinician-delivered CBT with tratment as usual Behavioral: cognitive behavioral therapy
12 weekly, individual sessions of manual-guided CBT delivered by trained clinician .


Outcome Measures
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Primary Outcome Measures :
  1. increase in the addiction severity index for methamphetamine use disorder [ Time Frame: 12 weeks ]
    0-1 No imminent problem 2-3 slight problem 4-5 moderate problem 6-7considerable difficulty


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who meet the criteria for methamphetamine use disorder according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) (10)
  • aged of 15-49 years' old
  • more than 9 year of education
  • urine drug screening positive for methamphetamine

Exclusion Criteria:

  • other Axis I disorder of DSM-V criteria such as bipolar disorder, schizophrenia, depression
  • Had a legal case pending resulting in inability to commit to 12 weeks of treatment.
  • Refusal to participate
  • poly drug dependence.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ahmad Tharwat Ahmad, Assistant lecture, Assiut University
ClinicalTrials.gov Identifier: NCT05593796    
Other Study ID Numbers: 715715
First Posted: October 25, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No