No registrations found.
ID
Source
Brief title
Health condition
cocaine addiction
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does varenicline reduce craving to cocaine and/or impulsivity in human cocaine users?
Secondary outcome
N/A
Background summary
A 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.
Study objective
Varenicline reduces craving to cocaine and/or impulsivity in human cocaine users.
Study design
All interventions are performed both before and after treatment, both for the placebo group and the varenicline-treated group.
Intervention
1. 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.
Amsterdam Institute for Addiction Research
Department of Psychiatry, PB0-436
P.O. Box 75867
Cleo L. Crunelle
Amsterdam 1070 AW
The Netherlands
+31 (0)20 8913763
c.l.crunelle@amc.uva.nl
Amsterdam Institute for Addiction Research
Department of Psychiatry, PB0-436
P.O. Box 75867
Cleo L. Crunelle
Amsterdam 1070 AW
The Netherlands
+31 (0)20 8913763
c.l.crunelle@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL1839 |
| NTR-old | NTR1949 |
| Other | METC Academic Medical Center : MEC 08/197 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |