The aims are: (1) to explore the feasibility of XRNT treatment in the Netherlands in terms of treatment participation and treatment retention; and (2) to study the mechanism of action of XRNT using pharmacoMRI and SPECT, and (3) to study the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
middelenafhankelijkheid (heroine)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Heroin dependence is a quintessential international health problem, with a
significant prevalence. In the Netherlands there are about 18,000 problematic
heroin users (NDM, 2010). Of these, almost 13,000 (70%) are in regular contact
with the treatment system: 11,000 in methadone maintenance treatment (MMT), 800
in heroin assisted treatment (HAT), and 1,200 in abstinence oriented treatment.
Average age is 44 years, only 6% is younger than 30 years, and only 5% are new
referrals with no previous treatment history. The vast majority are chronic
polydrug dependent patients with a long treatment history. Based on anecdotal
information, it seems that some of the new referrals, many of the patients in
abstinence treatments, and some of the patients in MMT and HAT are interested
in a life without opioids, i.e. without illegal
heroin or prescribed methadone or heroin. However, drug free treatments,
including pharmacologically supported interventions using oral naltrexone (NT),
have not been very successful, mainly due to low compliance. The recent
introduction of extended release naltrexon (XRNT) treatment, consisting of
monthly injections, may create new opportunities.
Injectable XRNT is an innovative treatment delivery method that blocks the
rewarding effects heroin, and possibly also alcohol and stimulants for at least
one month after injection. XRNT (Vivitrol®, Alkermes Inc, Cambridge, MA, USA)
has been approved by the US FDA for the treatment of opioid dependence in the
general population in October 2010.
Study objective
The aims are: (1) to explore the feasibility of XRNT treatment in the
Netherlands in terms of treatment participation and treatment retention; and
(2) to study the mechanism of action of XRNT using pharmacoMRI and SPECT, and
(3) to study the potential negative effect of XRNT on natural rewards.
Study design
Quasi-experimental design: pre and on XRNT assessments using brain fMRI and
SPECT.
Intervention
Three XRNT injections will be administered at 1-month intervals.
Study burden and risks
Patients will visit the AMC eight times: prior to the first XRNT injection
participants* eligibility for XRNT will be determined by history, biochemical
testing and the naloxone challenge test. Patients will receive three XRNT
injections at 1-month intervals. Two fMRI sessions and two SPECT sessions will
be conducted. In addition, participants will complete some questionnaires and
the site of injection will be inspected a week after injection.
Healthy controls will ondergo a MRI and SPECT scan once after completing some
questionnaires.
The anticipated risks associated with research participation are limited to the
possible side effects of depot naltrexone, which are relatively few.
The project will yield considerable information regarding the effectiveness of
depot naltrexone in reducing opioid use and reducing recidivism and may provide
information as to the best way to treat opioid dependence. Some subjects may
actually find participation to be beneficial in supporting their recovery.
Meibergdreef 5
Postbus 22660, 1100 DD AMSTERDAM ZUIDOOST
NL
Meibergdreef 5
Postbus 22660, 1100 DD AMSTERDAM ZUIDOOST
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001890-15-NL |
| CCMO | NL36681.018.11 |