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Feasibility, meachanism of action and potential side effects of extended release depot naltrexone (XRNT) in opioid dependent patients

Feasibility, meachanism of action and potential side effects of extended release depot naltrexone (XRNT) in opioid dependent patients - Extended release depot naltrexone

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35900
Enrollment
40
Registered
2011-10-27
Start date
2012-10-01
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

middelenafhankelijkheid (heroine) heroin dependence opioid dependence

Interventions

Three XRNT injections will be administered at 1-month intervals.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Heroin dependent patients: have a diagnosis of opioid dependence according to DSM-IV criteria. Healthy controls: no diagnosis of substance dependence, no current psychotropic medication. Care will be taken to match controls for gender, age and smoking status.

Exclusion criteria

Exclusion criteria: 1) Age below 18 or over 55 2) Medical contraindications for XRNT or MRI 3) Presence of disorders precluding normal perception of visual and auditory stimuli 4) Patients who are psychiatrically unstable 5) History or evidence of disorders that may affect cerebral function or circulation 6) Female subjects: women who are pregnant or breast-feeding

Design outcomes

Primary

MeasureTime frame
Brain functions of 20 heroin addicts just before and during a three month XRNT treatment using both functional MRI and dopamine transporter SPECT, compared to brain functions of 20 healthy controls. Adverse effects of XRNT on natural rewards. These changes in subjective experiences will be correlated with changes in dopamine transporter density (SPECT).

Secondary

MeasureTime frame
The feasibility and potential efficacy of XRNT in a small sample of 20 heroin addicts in terms of (a) the percentage of patients that actually starts XRNT treatment when invited and (b) the percentage of 3 months retention. Adverse events and side effects will also be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)