Serotonin transporter gene variation and sensitivity to conditioned cues: cause and cure in cocaine dependence

Serotonin transporter gene variation and sensitivity to conditioned cues: cause and cure in cocaine dependence - CocaSert-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40013

Enrollment

140

Registered

2012-06-18

Start date

2012-09-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

verslaving cocaine addiction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male subjects with cocaine dependence as defined in the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition (DSM-IV; American Psychiatric Association 1994), and will be determined by a structured interview (Composite International Diagnostic Interview: CIDI) aged 18-40 years. Controls: male healthy volunteers aged 18 - 50 years.

Exclusion criteria

Exclusion criteria: No cocaine dependence Positive DSM-IV/CIDI for any drug other than cocaine, heroin, alcohol or marijuana Major neurological disorders, claustrophobia, peripheral vascular diseases, current use of respiratory, cardiovascular, anticonvulsant or psychoactive medications (SSRIs), or alexithymia A positive urine test result for amphetamines, barbiturates, benzodiazepine metabolites, cocaine (metabolite), opiates, alcohol, and marijuana

Design outcomes

Primary

Measure	Time frame
- MRI: volume (mL) of all ROIs * - DTI: FA values within all ROIs * - BOLD: % change in BOLD signal within all ROIs, during fMRI tasks that assess emotional and rewardprocessing, fear conditioning and drug-cue reactivity* - BOLD: % change in BOLD signal within all ROIs during a cue-reactivity task * - 1H-MRS: resting state glutamate concentration in ACC and PFC (per voxel: glutamate/CSF) * - VAS: % change in VAS-scores for craving elicited by drug-related cues ** In all analysis, the ROIs are the vmPFC, the OFC, the ACC and the amygdala. * For these outcome measures the main study parameters are the difference between genotypes (s- or l-allele) and group (healthy controls or cocaine dependent patients) * For these outcome measures, the influence of the 5 other polymorphisms will be investigated in a exploratory analysis.	—

Measure

Time frame

- MRI: volume (mL) of all ROIs * - DTI: FA values within all ROIs * - BOLD: % change in BOLD signal within all ROIs, during fMRI tasks that assess emotional and rewardprocessing, fear conditioning and drug-cue reactivity* - BOLD: % change in BOLD signal within all ROIs during a cue-reactivity task * - 1H-MRS: resting state glutamate concentration in ACC and PFC (per voxel: glutamate/CSF) * - VAS: % change in VAS-scores for craving elicited by drug-related cues ** In all analysis, the ROIs are the vmPFC, the OFC, the ACC and the amygdala. * For these outcome measures the main study parameters are the difference between genotypes (s- or l-allele) and group (healthy controls or cocaine dependent patients) * For these outcome measures, the influence of the 5 other polymorphisms will be investigated in a exploratory analysis.

—

Secondary

Measure	Time frame
n.a	—

Countries

Netherlands

Outcome results