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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05593796

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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 .

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Tharwat Ahmad, Assistant lecture, Assiut University

ClinicalTrials.gov Identifier:

NCT05593796

Other Study ID Numbers:

715715

First Posted:

Oct 25, 2022

Last Update Posted:

Feb 3, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 3, 2023