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Deep Brain Stimulation in Chronic Treatment refractory Drug Dependence: A Pilot Study

Deep Brain Stimulation in Chronic Treatment refractory Drug Dependence: A Pilot Study - DBS in addiction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35020
Enrollment
8
Registered
2010-03-04
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

treatment resistant drug dependence untreatable addiction

Interventions

The intervention of this study will be Deep Brain Stimulation (DBS) in the Nucleus Accumbens (NcAcc) in all participants. Deep Brain Stimulation is an adjustable, reversible, non-destructive interve

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Chronic course of substance use disorder: minimal duration of 5 years of DSM-IV diagnosis heroin and/or cocaine dependence - Being treatment refractory despite treatment programs - Severe dependence: heroin/cocaine use at least 15 days in last month AND poor physical health AND/OR poor mental health AND/OR poor social functioning

Exclusion criteria

Exclusion criteria: - Current major depression, current suicidality, current OCD. - Current psychosis and no history of psychosis - (history of) severe neurological disorders - Contraindication to perform the operation - Contraindication to participate in fMRI and/or SPECT assesment

Design outcomes

Primary

MeasureTime frame
Primary outcome measurements include subjective craving and illicit drug use. In addition, urinalysis will be performed to validate self-reported drug use. Concerning the imaging experiments the outcome will be assessed by changes in brain activity with fMRI and changes in striatal dopamine D2 binding with SPECT.

Secondary

MeasureTime frame
Secondary outcomes include social function and quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)