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van CCT (UK)

Innovative approaches for cocaine pharmacotherapy using fMRI: the case of varenicline.

- candidate number6307
- NTR NumberNTR1949
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2009
- Secondary IDsMEC 08/197 METC Academic Medical Center
- Public TitleInnovative approaches for cocaine pharmacotherapy using fMRI: the case of varenicline.
- Scientific TitleInnovative approaches for cocaine pharmacotherapy using fMRI: the case of varenicline.
- hypothesisVarenicline reduces craving to cocaine and/or impulsivity in human cocaine users.
- Healt Condition(s) or Problem(s) studiedCocain addiction
- Inclusion criteria1. Male, age 18-60 years;
2. Current DSM-IV diagnosis of cocaine dependence, but recently detoxified and abstinent;
3. Able to provide written informed consent and to comply with all study procedures.
- Exclusion criteria1. Currently dependent on any substance other than cocaine or nicotine;
2. History of depression that could be defined as even a single episode or recurrent episodes of depression, or depression necessitating hospitalization, or history of suicide attempt (see fotenote1);
3. Severe neurological or psychiatric disorders (e.g., psychosis, bipolar illness, dementia, or any diseases that require psychotropic medications);
4. Serious medical illnesses;
5. Known hypersensitivity or allergy to varenicline, or receiving chronic therapy with medication that could interact adversely with one of the medications under study, within 30 days prior to randomization;
6. Drugs known to influence binding to DA2 receptors, including neuroleptics, and methylphenidate;
7. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment;
8. Clinically significant abnormal laboratory values, as measured by the treatment centre;
9. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication;
10. Hypersensitivity to Jodium.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate10-jan-2013
- Target number of participants30
- Interventions1. Study medication (varenicline 1mg twice daily);
2. fMRI scanning before and after treatment;
3. fMRI scanning after a single dose of varenicline;
4. SPECT scanning using the radioligand 123I-IBZM before and after treatment;
5. Neurocognitive tasks and questionnaires;
6. Blood and urine collections.
- Primary outcomeDoes varenicline reduce craving to cocaine and/or impulsivity in human cocaine users?
- Secondary outcomeN/A
- TimepointsAll interventions are performed both before and after treatment, both for the placebo group and the varenicline-treated group.
- Trial web siteN/A
- statusrecruitement status not public
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryA goal of the proposed study is to build knowledge for an evidence-based strategy to reduce relapse by cocaine addicts. To accomplish this, we propose to:
1. Investigate effects of prolonged treatment with varenicline (an alpha4-beta2 nicotinic receptor partial agonism) on the availability of dopamine D2 receptors in abstinent cocaine addicts;
2. Examine the acute and prolonged effects of varenicline on impulse control, motivational strength of drug cues, and brain activation patterns of cocaine-addicted patients compared to non-addicted controls (using fMRI);
3. Examine the extent to which these processes predict relapse.
- Main changes (audit trail)
- RECORD11-aug-2009 - 11-okt-2009

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