Cognitive Behavioral Therapy(CBT) in Treatment of Methamp... | NCT05593796

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

NCT05593796

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Methamphetamine Abuse

Interventions

cognitive behavioral therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Oct 24, 2022

First Submission Date that Met QC Criteria

Oct 24, 2022

First Posted Date

Oct 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2023

Last Update Posted Date

Aug 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmad Tharwat Ahmad, Assistant lecture, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The efficacy of cognitive behavioral therapy(CBT) in treatment of methamphetamine use disorder

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment-as-usual (TAU)	Active Comparator		Behavioral: cognitive behavioral therapy
Clinician-delivered CBT with tratment as usual	Active Comparator		Behavioral: cognitive behavioral therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive behavioral therapy	Behavioral	12 weekly, individual sessions of manual-guided CBT delivered by trained clinician .	Clinician-delivered CBT with tratment as usual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase in the addiction severity index for methamphetamine use disorder	0-1 No imminent problem 2-3 slight problem 4-5 moderate problem 6-7considerable difficulty	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided

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.