Substance Use DisorderRe@dictNCT02308878
Mobile Health Cognitive Stimulation in Heroin Users
A study testing Mobile health cognitive stimulation in people with Substance Use Disorder, run by Pedro Gamito at 1 site in Portugal.
Trial summary
Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Mobile health cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2013to Jan 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study.
Who cannot join
- Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
Sintra, Lisbon District, 2725
About this study
Official title: Executive Functioning in Heroin Users Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.
- Conditions
- Substance Use Disorder
- Being tested
- Mobile health cognitive stimulation
- Keywords
- Opioid Abuse Disorder, Cognitive Therapy, Executive Function, Mobile Health, Rehabilitation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health cognitive stimulationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | No intervention | This group consists of treatment-as-usual for opioid dependence syndrome. |
| Mobile health cognitive stimulation | Experimental | Cognitive stimulation using mobile technology with m-Health applications. Receives: Behavioral: Mobile health cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the results of Frontal Assessment Battery - FAB
The participants were assessed in frontal lobe functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro Gamito
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Lusófona de Humanidades e Tecnologias, Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
- Responsible party
- Sponsor-investigator, Pedro Gamito, Universidade Lusófona de Humanidades e Tecnologias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308878
- Sponsor's protocol ID
- SLB_SUD01
- Acronym
- Re@dict
- Status last verified
- May 2023
- First submitted
- 2 Dec 2014
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning in Heroin Users Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02308878
- Acronym / sponsor ID
- Re@dict / SLB_SUD01
- Conditions
- Substance Use Disorder
- Keywords
- Opioid Abuse Disorder, Cognitive Therapy, Executive Function, Mobile Health, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pedro GamitoUniversity, hospital or other
- Collaborators
- Universidade Lusófona de Humanidades e Tecnologias, Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
- Study start
- Oct 2013
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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.
Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | No intervention | –This group consists of treatment-as-usual for opioid dependence syndrome. |
| Mobile health cognitive stimulation | Experimental | Behavioral: Mobile health cognitive stimulationCognitive stimulation using mobile technology with m-Health applications. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study.
Key exclusion criteria (1 listed)
- Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.
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 |
|---|---|---|
| Mobile health cognitive stimulation | Behavioural | Mobile health cognitive stimulation |
Primary outcome
Change in the results of Frontal Assessment Battery - FAB
Time frame: 1 month
The participants were assessed in frontal lobe functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
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 11 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health cognitive stimulation in people with Substance Use Disorder, run by Pedro Gamito at 1 site in Portugal.
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 1 inclusion and 1 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 11 May 2023. 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 Portugal. 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 in the results of Frontal Assessment Battery - FAB (time frame: 1 month). 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 11 May 2023.