NCT05593796

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

October 24, 2022

Last Update Submit

August 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

treatment-as-usual (TAU)

ACTIVE COMPARATOR
Behavioral: cognitive behavioral therapy

Clinician-delivered CBT with tratment as usual

ACTIVE COMPARATOR
Behavioral: cognitive behavioral therapy

Interventions

12 weekly, individual sessions of manual-guided CBT delivered by trained clinician .

Clinician-delivered CBT with tratment as usualtreatment-as-usual (TAU)

Eligibility Criteria

Age15 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecture

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 25, 2022

Study Start

September 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08