Substance DependencyNCT02119949
Working Memory Training for Substance Dependent Individuals
A study testing Working memory training in people with Substance Dependency and Addiction, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction. Read more about this study
- Who is it for?
- Ages 16 to 67 years
- Conditions the study is for
- Substance Dependency, Addiction, Anxiety
- What is being tested?
- Working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Jun 2014
- 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 16 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Substance dependency: cocaine, cannabis or alcohol
Who cannot join
- Age below 16 or above 67
- Current psychosis
- Neurological complaints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blind Placebo-controlled Trial to Working Memory Training in Substance Abusers
Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction.
Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance use, craving, WMC, impulsivity, attention bias and psychopathology.
Read more
Design: A randomized double-blind placebo-controlled trial with a parallel group design. The WM training adapted to participants' WMC whereas the placebo training consisted of non-adaptive easy versions of these tasks.
Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.
Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual .
Measurements: Primary outcome measures: Substance use and craving. Secondary outcome measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed before and after 24 sessions of WM training as well as two months after the training.
- Conditions
- Substance Dependency, Addiction, Anxiety, Depression
- Being tested
- Working memory training, Placebo training
- Keywords
- Substance abuse, Addiction, Working memory, Craving, Impulsivity, Attention control
- Medical subject headings
- Behavior, Addictive, Anxiety Disorders, Depression, Substance-Related Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the experimental group executed versions of these task that adapt to their working memory capacity, to train their working memory optimally.
Placebo trainingBehavioural
The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the placebo group executed easy versions of these task that did not adapt to their level, to prevent training.
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Experimental | Not described Receives: Behavioral: Working memory training |
| Placebo training | Placebo comparator | Not described Receives: Behavioral: Placebo training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving: Desires for Alcohol Questionnaire and Desires for Drug Questionnaire score change and Obsessive Compulsive Drug Use Scale and Obsessive Compulsive Drinking Scale score change between pre and post training and follow up (two months after post)
The 14-item Desires for Drug Questionnaire (DDQ) and the 13-item Desires for Alcohol Questionnaire (DAQ) measure instant craving to respectively drug and alcohol. The DDQ is based on the DAQ.
The Obsessive Compulsive Drug Use Scale (OCDUS) and Obsessive Compulsive Drinking Scale (OCDS) measure the subjective interference and distress caused by respectively drug and alcohol related thoughts and compulsive-behavior patterns.
Measured: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Secondary outcomes (2)
Change in Digit Span score on pre and post training and follow up after two months
The Digit Span task consists of two parts: the forward Digit Span is a frequently used measure for short term memory, an important subcomponent of the memory system (Shipstead, Redick, \& Engle, 2012) and the backward version measures WM.
Measured: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Change in Reading Span partial-scredit uni score on pre and post training and follow up after two months
The Reading Span measures the processing and storage functions of WM (Shipstead et al., 2012), specifically participants' ability to shift between two tasks and to cope with proactive interference.
Measured: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependencyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingmar Franken, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119949
- Sponsor's protocol ID
- 2
- Status last verified
- Aug 2014
- First submitted
- 8 Apr 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Trial to Working Memory Training in Substance Abusers
- ClinicalTrials.gov ID
- NCT02119949
- Acronym / sponsor ID
- 2
- Conditions
- Substance Dependency, Addiction, Anxiety, Depression
- Keywords
- Substance abuse, Addiction, Working memory, Craving, Impulsivity, Attention control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Apr 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.
Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction.
Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance use, craving, WMC, impulsivity, attention bias and psychopathology.
Design: A randomized double-blind placebo-controlled trial with a parallel group design. The WM training adapted to participants' WMC whereas the placebo training consisted of non-adaptive easy versions of these tasks.
Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.
Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual .
Measurements: Primary outcome measures: Substance use and craving. Secondary outcome measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed before and after 24 sessions of WM training as well as two months after the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working memory training | Experimental | Behavioral: Working memory training |
| Placebo training | Placebo comparator | Behavioral: Placebo training |
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Substance dependency: cocaine, cannabis or alcohol
Key exclusion criteria (3 listed)
- Age below 16 or above 67
- Current psychosis
- Neurological complaints
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 |
|---|---|---|
| Working memory trainingThe working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the experimental group executed versions of these task that adapt to their working memory capacity, to train their working memory optimally. | Behavioural | Working memory training |
| Placebo trainingThe working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the placebo group executed easy versions of these task that did not adapt to their level, to prevent training. | Behavioural | Placebo training |
Primary outcome
Craving: Desires for Alcohol Questionnaire and Desires for Drug Questionnaire score change and Obsessive Compulsive Drug Use Scale and Obsessive Compulsive Drinking Scale score change between pre and post training and follow up (two months after post)
Time frame: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
The 14-item Desires for Drug Questionnaire (DDQ) and the 13-item Desires for Alcohol Questionnaire (DAQ) measure instant craving to respectively drug and alcohol. The DDQ is based on the DAQ. The Obsessive Compulsive Drug Use Scale (OCDUS) and Obsessive Compulsive Drinking Scale (OCDS) measure the subjective interference and distress caused by respectively drug and alcohol related thoughts and compulsive-behavior patterns.
2 secondary outcomes
Change in Digit Span score on pre and post training and follow up after two months
Time frame: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
Change in Reading Span partial-scredit uni score on pre and post training and follow up after two months
Time frame: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)
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 21 Aug 2014.
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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 Working memory training in people with Substance Dependency and Addiction, run by Erasmus Medical Center at 1 site in Netherlands.
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 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 21 Aug 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Craving: Desires for Alcohol Questionnaire and Desires for Drug Questionnaire score change and Obsessive Compulsive Drug Use Scale and Obsessive Compulsive Drinking Scale score change between pre and post training and follow up (two months after post) (time frame: Pre (baseline), post (after 4 weeks of training-starting 1 day after pre-test) and follow-up (2 months after post-test)). 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 21 Aug 2014.