Substance Use DisordersPhase 2NCT01271413
Cognitive Stimulation
A Phase 2 study testing Computerized cognitively stimulating activities in people with Substance Use Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Computerized cognitively stimulating activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-55
- in methadone maintenance or healthy volunteers
- healthy
Who cannot join
- Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
- severe cognitive impairment
- serious untreated medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
BPRU, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Effects of Cognitive Training in Methadone Maintenance Patients
This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.
- Conditions
- Substance Use Disorders
- Being tested
- Computerized cognitively stimulating activities
- 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 cognitively stimulating activitiesBehavioural
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 |
|---|---|---|
| Adaptive cognitively stimulating activities | Experimental | Not described Receives: Behavioral: Computerized cognitively stimulating activities |
| Non-adaptive cognitively stimulating activities | Active comparator | Not described Receives: Behavioral: Computerized cognitively stimulating activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory
Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks
Measured: baseline, 7 weeks
Secondary outcomes (6)
Episodic Memory
Measured: baseline, 7 weeks
Trail-making
Measured: baseline, 7 weeks
go/No-go
Measured: baseline, 7 weeks
Addiction Severity Index
Measured: baseline, 7 weeks
Delay Discounting
Measured: baseline, 7 weeks
Digit Symbol Substitution Test
Measured: baseline, 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 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, Miriam Mintzer, Johns Hopkins University
- Investigators
- Miriam Z Mintzer, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271413
- Sponsor's protocol ID
- NA_00042772
- Other IDs
- 1R21DA029708
- Status last verified
- Mar 2014
- First submitted
- 5 Jan 2011
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rass O, Schacht RL, Buckheit K, Johnson MW, Strain EC, Mintzer MZ. A randomized controlled trial of the effects of working memory training in methadone maintenance patients. Drug Alcohol Depend. 2015 Nov 1;156:38-46. doi: 10.1016/j.drugalcdep.2015.08.012. Epub 2015 Aug 24.
PubMed 26404954
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Training in Methadone Maintenance Patients
- ClinicalTrials.gov ID
- NCT01271413
- Acronym / sponsor ID
- NA_00042772
- Conditions
- Substance Use Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Posted 7 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive cognitively stimulating activities | Experimental | Behavioral: Computerized cognitively stimulating activities |
| Non-adaptive cognitively stimulating activities | Active comparator | Behavioral: Computerized cognitively stimulating activities |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-55
- in methadone maintenance or healthy volunteers
- healthy
Key exclusion criteria (3 listed)
- Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
- severe cognitive impairment
- serious untreated medical condition
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 cognitively stimulating activitiesThe study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks. | Behavioural | Adaptive cognitively stimulating activities, Non-adaptive cognitively stimulating activities |
Primary outcome
Working Memory
Time frame: baseline, 7 weeks
Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks
6 secondary outcomes
Episodic Memory
Time frame: baseline, 7 weeks
Trail-making
Time frame: baseline, 7 weeks
go/No-go
Time frame: baseline, 7 weeks
Addiction Severity Index
Time frame: baseline, 7 weeks
Delay Discounting
Time frame: baseline, 7 weeks
Digit Symbol Substitution Test
Time frame: baseline, 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26404954Rass O, Schacht RL, Buckheit K, Johnson MW, Strain EC, Mintzer MZ. A randomized controlled trial of the effects of working memory training in methadone maintenance patients. Drug Alcohol Depend. 2015 Nov 1;156:38-46. doi: 10.1016/j.drugalcdep.2015.08.012. Epub 2015 Aug 24.
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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.
Miriam Z Mintzer, 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 cognitively stimulating activities 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 3 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 16 Apr 2014. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: baseline, 7 weeks). 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 NCT01271413, 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 16 Apr 2014.