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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22626
Enrollment
30
Registered
2009-08-11
Start date
2009-01-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cocaine addiction

Interventions

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.

Sponsors

AMC Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Does varenicline reduce craving to cocaine and/or impulsivity in human cocaine users?

Contacts

Public ContactCleo L. Crunelle

Academic Medical Center, University of Amsterdam Amsterdam Institute for Addiction Research Department of Psychiatry, PB0-436 P.O. Box 75867

c.l.crunelle@amc.uva.nl+31 (0)20 8913763

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)