Amphetamine AddictionNCT03318081
The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
A study testing cognitive function rehabilitation and bias modification in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amphetamine Addiction
- What is being tested?
- cognitive function rehabilitation and bias modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2017to 1 May 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosed MA dependence in accordance with the fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (Association, 2000);
- more than 9 years of education;
- aged of 18-60 years old;
- normal vision, audition and no color blindness;
- receive no detoxification medications during treatment and
- right handedness.
Who cannot join
- current medical diseases that required hospitalization or regular monitoring;
- serious physical or neurological illness that required pharmacological treatment affecting cognitive function;
- history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence;
- neurological diseases such as stroke, seizure, migraine, head trauma
- substance dependence other than nicotine, within the past 5 years;
- intelligence quotient (IQ) <70.
Trial locations and contacts
1 site in 1 country.
About this study
The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction.
Read the detailed description
The deficits in executive functions related to prefrontal-striatal circuits play a vital role in ATS addiction and relapse, and proposed computerized cognitive rehabilitation therapy as the novel interventions. Focused on evaluating and training executive functions including working memory, inhibitory control, cognitive flexibility, and congitive bias concerning prefrontal-striatal circuits, neuropsychological tests, electroencephalography tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to evaluate the therapeutic effect of ATS addiction treatment as well as investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.
- Conditions
- Amphetamine Addiction
- Being tested
- cognitive function rehabilitation and bias modification
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, cognitive rehabilitation therapy
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive function rehabilitation and bias modificationBehavioural
cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
| Study group | Role | What they receive |
|---|---|---|
| cognitive function rehabilitation group | Active comparator | The main content of cognitive function rehabilitation esecutive function,including working memory,sustained attention, response inhibition function and cognitive flexibility, 45 minutes a day over 6 weeks period. Receives: Behavioral: cognitive function rehabilitation and bias modification |
| cognitive bias modification group | Active comparator | The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period. Receives: Behavioral: cognitive function rehabilitation and bias modification |
| control group | No intervention | Participants only accept the regular scheduled in the compulsory isolated detoxification center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months
evaluate all participants' craving for ATS by Visual Analog Scales (VAS): The scores of the VAS were 0-10 points. 10 points reflect the highest level of individual's craving, and 0 point reflect no craving in patient.
Measured: Baseline, 1 month, 3 month and 6 months
Secondary outcomes (3)
Cognitive function assessed by CogState Battery (CSB)
evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version: The five tasks listed below were examined. International shopping list task (ISLT, verbal learning and memory), the score is defined as the total number of correct responses. Continuous paired association learning task (CPAL) taps spatial working memory. Groton maze learning task (GML) taps problem solving/error monitoring. The scores of CPAL and GML tasks are the total number of errors. Social emotional cognition task (SEC, social cognition) asks the subjects to pick out the different facial expressions. Two back task (TWOB, working memory) requires subjects to decide whether a card is identical to the one shown just before. The scores of TWOB and SEC tasks are the proportion of correct responses, denoting the accuracy of performance. The higher values represent a better outcome in ISL, SEC and TWOB. The higher values represent a worse outcome in GML and CPAL.
Measured: Baseline, 1 month, 3 month and 6 months
Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)
evaluate all participants' response inhibition function by Balloon Analogue Risk Task (BART): Several indices were computed to represent the behavioral performance, including the ratio of all pumps to numbers of win trials, the ratio of pumps to numbers in win trials, and the number of win trials. The higher values represent a worse outcome.
Measured: Baseline, 1 month, 3 month and 6 months
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.
Measured: 1 month, 3 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start20 Oct 2017
- Primary completion31 Dec 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amphetamine AddictionStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Min, PhD, MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318081
- Sponsor's protocol ID
- MZhao-008
- Status last verified
- Jan 2020
- First submitted
- 15 Oct 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Y, Jiang H, Su H, Zhong N, Li R, Li X, Chen T, Tan H, Du J, Xu D, Yan H, Xu D, Zhao M. A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10292. doi: 10.2196/10292.
PubMed 29925497
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
- ClinicalTrials.gov ID
- NCT03318081
- Acronym / sponsor ID
- MZhao-008
- Conditions
- Amphetamine Addiction
- Keywords
- Amphetamine-type stimulants, prefrontal-striatal circuits, cognitive rehabilitation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 23 Oct 2017 (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 computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction.
Detailed description
The deficits in executive functions related to prefrontal-striatal circuits play a vital role in ATS addiction and relapse, and proposed computerized cognitive rehabilitation therapy as the novel interventions. Focused on evaluating and training executive functions including working memory, inhibitory control, cognitive flexibility, and congitive bias concerning prefrontal-striatal circuits, neuropsychological tests, electroencephalography tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to evaluate the therapeutic effect of ATS addiction treatment as well as investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive function rehabilitation group | Active comparator | Behavioral: cognitive function rehabilitation and bias modificationThe main content of cognitive function rehabilitation esecutive function,including working memory,sustained attention, response inhibition function and cognitive flexibility, 45 minutes a day over 6 weeks period. |
| cognitive bias modification group | Active comparator | Behavioral: cognitive function rehabilitation and bias modificationThe main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period. |
| control group | No intervention | –Participants only accept the regular scheduled in the compulsory isolated detoxification center |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosed MA dependence in accordance with the fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (Association, 2000);
- more than 9 years of education;
- aged of 18-60 years old;
- normal vision, audition and no color blindness;
- receive no detoxification medications during treatment and
Key exclusion criteria (6 listed)
- current medical diseases that required hospitalization or regular monitoring;
- serious physical or neurological illness that required pharmacological treatment affecting cognitive function;
- history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence;
- neurological diseases such as stroke, seizure, migraine, head trauma
- substance dependence other than nicotine, within the past 5 years;
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 function rehabilitation and bias modificationcognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias | Behavioural | cognitive bias modification group, cognitive function rehabilitation group |
Primary outcome
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months
Time frame: Baseline, 1 month, 3 month and 6 months
evaluate all participants' craving for ATS by Visual Analog Scales (VAS): The scores of the VAS were 0-10 points. 10 points reflect the highest level of individual's craving, and 0 point reflect no craving in patient.
3 secondary outcomes
Cognitive function assessed by CogState Battery (CSB)
Time frame: Baseline, 1 month, 3 month and 6 months
Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)
Time frame: Baseline, 1 month, 3 month and 6 months
Number of participants who relapse
Time frame: 1 month, 3 month and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 29925497Zhu Y, Jiang H, Su H, Zhong N, Li R, Li X, Chen T, Tan H, Du J, Xu D, Yan H, Xu D, Zhao M. A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10292. doi: 10.2196/10292.
- Individual participant dataSharing planned: No
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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.
Zhao Min, PhD, MD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive function rehabilitation and bias modification in people with Amphetamine Addiction, run by Shanghai Mental Health Center at 1 site in China.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months (time frame: Baseline, 1 month, 3 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318081, which also lists 1 linked publication.
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 13 Jan 2020.