Methamphetamine AbuseNCT05593796
Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder
A study testing cognitive behavioral therapy in people with Methamphetamine Abuse, run by Assiut University.
Trial summary
The efficacy of cognitive behavioral therapy(CBT) in treatment of methamphetamine use disorder Read more about this study
- Who is it for?
- Ages 15 to 50 years, men only
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Efficacy of Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder
The efficacy of cognitive behavioral therapy(CBT) in treatment of methamphetamine use disorder
Read the 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
- Conditions
- Methamphetamine Abuse
- Being tested
- cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
12 weekly, individual sessions of manual-guided CBT delivered by trained clinician .
| Study group | Role | What they receive |
|---|---|---|
| treatment-as-usual (TAU) | Active comparator | Not described Receives: Behavioral: cognitive behavioral therapy |
| Clinician-delivered CBT with tratment as usual | Active comparator | Not described Receives: Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Tharwat Ahmad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593796
- Sponsor's protocol ID
- 715715
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cognitive Behavioral Therapy(CBT) in Treatment of Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT05593796
- Acronym / sponsor ID
- 715715
- Conditions
- Methamphetamine Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| treatment-as-usual (TAU) | Active comparator | Behavioral: cognitive behavioral therapy |
| Clinician-delivered CBT with tratment as usual | Active comparator | Behavioral: cognitive behavioral therapy |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy12 weekly, individual sessions of manual-guided CBT delivered by trained clinician . | Behavioural | Clinician-delivered CBT with tratment as usual, treatment-as-usual (TAU) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Methamphetamine Abuse, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in the addiction severity index for methamphetamine use disorder (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.