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- candidate number16661
- NTR NumberNTR4474
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2014
- Secondary IDsNL54240 CCMO
- Public TitleTake Control!
- Scientific TitleTake Control! - Targeting Cocaine Dependence by Targeting Underlying Cognitive Processes
- ACRONYMTake Control!
- hypothesis- Working memory training is effective to treat heavy cocaine use
- N-acetylcysteine treatment is effective to treat heavy cocaine use
- the combination of both is expected to be most effective
- Healt Condition(s) or Problem(s) studiedCocaine dependence, Addiction
- Inclusion criteria1. males
2. 18 -60 years old
3. minimal 2 DSM-5 critieria AND using cocaine at least 4 times per month
- Exclusion criteria1. Major illnesses;
2. Two or more DSM-5 substance use disorder criteria for heroin
3. Ulcers;
4. MRI incompatibility
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2014
- planned closingdate31-dec-2015
- Target number of participants100
- Interventions- 25 days working memory or placebo training - 25 days 2400 mg/d N-Acetylcysteine capsules or placebo capsules This results in 4 groups: (1) working memory training and N-acetylcysteine, (2) working memory training and placebo capsules, (3) placebo training and n-acetylcysteine, (4) placebo training and placebo capsules
- Primary outcome- cocaine use
-glutamatergic concentrations in the dorsal ACC and rostral ACC
- working memory improvement
- craving
- Secondary outcome- cue reactivity
- Timepointst0= baseline measures before treatment;
t1-t25= daily intermediate measure at home during treatment + 5 times contact by phone;
t26= post-treatment measures;
t27= follow-up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Mieke Mors-Schulte, ter
- CONTACT for SCIENTIFIC QUERIES Mieke Mors-Schulte, ter
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-mrt-2014 - 19-apr-2014


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