Contact information
Type
Scientific
Primary contact
Prof Jari Tiihonen
ORCID ID
Contact details
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
+ 358 (0)17 203 202
jari.tiihonen@niuva.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
84/24.9.2007
Study information
Scientific title
Naltrexone depot implant in the treatment of co-morbid amphetamine and opioid dependence: a double-blind, randomised, placebo-controlled trial
Acronym
Study hypothesis
The purpose of this study is to compare the efficacy of naltrexone depot implant (Prodetoxone) with placebo in reducing amphetamine and opioid use among patients having amphetamine (or methamphetamine) and opioid dependence.
As of 22/12/2009 this record has been updated in response to changes in the protocol. All updates can be found under the relevant field with the above update date. At this time, the anticipated start and end dates of this trial were updated; the initial trial dates were:
Initial anticipated start date: 10/11/2007
Initial anticipated end date: 31/12/2009
At this time, the sponsor was also updated; the initial sponsor of this trial was the National Research and Development Centre for Welfare and Health (STAKES) (Finland).
Ethics approval
Ethics approval received from the Independent Ethical Committee, St. Petersburg State Pavlov Medical University on the 24th September 2007 (ref: 84).
Study design
A parallel double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Amphetamine and opioid dependence (DSM-IV)
Intervention
The naltrexone arm will receive Naltrexone depot implant (Prodotoxone) (containing 1000 mg of naltrexone), and the placebo arm will receive an identical-looking placebo implant. The patient receive only one implant in the beginning of the study and the follow-up is 10 weeks for both arms.
Intervention type
Drug
Phase
Not Applicable
Drug names
Naltrexone (Prodetoxone)
Primary outcome measure
Current information as of 22/12/2009:
1. Retention in the study
2. The proportion of urine samples, which are free of both amphetamine and opioids ("totally clean") during the follow-up. Missing samples are considered as amphetamine and opioid positive samples.
3. Improvement in Clinical Global Impression (CGI) during the follow-up
Initial information at time of registration:
1. Amphetamine concentration in the urine samples and proportion of amphetamine-negative urine samples in each arm, obtained each week
2. Proportion of opioid-dependent patients (assessed with naloxone challenge test) in each arm, measured at at week 10
Secondary outcome measures
Current information as of 22/12/2009:
1. The proportion of amphetamine free urine samples during the follow-up. Missing samples are considered as amphetamine positive samples.
2. The proportion of opioid free urine samples during the follow-up. Missing samples are considered as opioid positive samples.
3. Global Assessment of Functioning (GAF)
4. Number of days amphetamine used during follow-up
5. Adverse events
Initial information at time of registration:
Proportion of benzodiazepine-negative and cannabinoid-negative urine samples, obtained each week.
Overall trial start date
01/03/2008
Overall trial end date
28/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary diagnosis of current Amphetamine and Opioid Dependence (Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV]), present for at least one year
2. Age between 18 and 50 years
3. Education as high school graduate or above
4. Negative urine toxicology and alcohol breath tests
5. Not currently on psychotropic medication
6. At least one relative willing to participate in treatment, monitor administration of medications, assist in follow-up, and provide outcome data
7. Stable address within St. Petersburg or nearest districts of Leningrad Region
8. Home telephone number at which the patient can be reached
9. Negative pregnancy test and use adequate contraception if of childbearing age
10. Willingness and ability to give informed consent and otherwise participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 patients
Total final enrolment
100
Participant exclusion criteria
1. Clinically significant cognitive impairment, schizophrenia, paranoid disorder, bipolar disorder, or seizure disorder
2. Advanced neurological, cardiovascular, renal, or hepatic disease
3. Active tuberculosis or current febrile illness
4. Acquired Immune Deficiency Syndrome (AIDS)-defining illness
5. Significant laboratory abnormality such as severe anaemia, unstable diabetes, or liver function tests greater than 3 x above normal
6. Pregnancy
7. Pending legal charges with potential impending incarceration
8. Concurrent participation in another treatment study
9. Concurrent treatment in another substance abuse program
Recruitment start date
01/03/2008
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
Sponsor information
Organisation
National Institute for Health and Welfare (THL) (Finland)
Sponsor details
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
+358 (0)17 203 111
jari.tiihonen@niuva.fi
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Current information as of 22/12/2009:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health and Social Affairs (Finland) - National Institute for Health and Welfare (THL) and EVO-subsidies from Niuvanniemi Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Initial information at time of registration:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health and Social Affairs (Finland) - Government of Finland, from National Research and Development Centre for Welfare and Health (STAKES) and EVO-subsidies from Niuvanniemi Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22764364 (added 21/08/2019)