Substance Use DisordersPhase 2NCT01948674
Cognitive Stimulation in Adolescents
A Phase 2 study testing Computerized tasks in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Computerized tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 2
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 14-21
- Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse
- eligible for intensive outpatient treatment
Who cannot join
- Untreated psychiatric disorder that might make participation hazardous
- Any condition associated with severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Manor Treatment Center
Baltimore, Maryland, 21229
About this study
Official title: Cognitive Training in Adolescents During Treatment for Substance Use Disorders
The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.
- Conditions
- Substance Use Disorders
- Being tested
- Computerized tasks
- 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.
Computerized tasksBehavioural
The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| computerized tasks- adaptive | Experimental | Not described Receives: Behavioral: Computerized tasks |
| computerized tasks - nonadaptive | Active comparator | Not described Receives: Behavioral: Computerized tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
working memory (change from baseline)
Measured: expected within 2 weeks after intervention
Secondary outcomes (7)
timeline follow back (change from baseline)
Measured: expected within 2 weeks after intervention
delay discounting (change from baseline)
Measured: expected within 2 weeks after intervention
Stroop (change from baseline)
Measured: expected within 2 weeks after intervention
reading comprehension (change from baseline)
Measured: expected within 2 weeks after intervention
emotion regulation (change from baseline)
Measured: expected within 2 weeks after intervention
Go-No Go (change from baseline)
Measured: expected within 2 weeks after intervention
Global Appraisal of Individual Needs (change from baseline)
Measured: expected within 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Matthew Johnson, Johns Hopkins University
- Investigators
- Matthew W Johnson, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948674
- Sponsor's protocol ID
- NA_00080023
- Other IDs
- R21DA034942
- Status last verified
- Aug 2016
- First submitted
- 17 Sep 2013
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Adolescents During Treatment for Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01948674
- Acronym / sponsor ID
- NA_00080023
- Conditions
- Substance Use Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Sep 2013 (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.
The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computerized tasks- adaptive | Experimental | Behavioral: Computerized tasks |
| computerized tasks - nonadaptive | Active comparator | Behavioral: Computerized tasks |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 14-21
- Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse
- eligible for intensive outpatient treatment
Key exclusion criteria (2 listed)
- Untreated psychiatric disorder that might make participation hazardous
- Any condition associated with severe cognitive impairment
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 |
|---|---|---|
| Computerized tasksThe study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks. | Behavioural | computerized tasks - nonadaptive, computerized tasks- adaptive |
Primary outcome
working memory (change from baseline)
Time frame: expected within 2 weeks after intervention
7 secondary outcomes
timeline follow back (change from baseline)
Time frame: expected within 2 weeks after intervention
delay discounting (change from baseline)
Time frame: expected within 2 weeks after intervention
Stroop (change from baseline)
Time frame: expected within 2 weeks after intervention
reading comprehension (change from baseline)
Time frame: expected within 2 weeks after intervention
emotion regulation (change from baseline)
Time frame: expected within 2 weeks after intervention
Go-No Go (change from baseline)
Time frame: expected within 2 weeks after intervention
Global Appraisal of Individual Needs (change from baseline)
Time frame: expected within 2 weeks after intervention
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 24 Aug 2016.
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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.
Matthew W Johnson, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computerized tasks in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
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 3 inclusion and 2 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 24 Aug 2016. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
working memory (change from baseline) (time frame: expected within 2 weeks after intervention). 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 24 Aug 2016.