Naltrexone depot implant in the treatment of co-morbid amphetamine and opioid dependence

ISRCTN	ISRCTN88905555
DOI	https://doi.org/10.1186/ISRCTN88905555
Protocol serial number	84/24.9.2007
Sponsor	National Institute for Health and Welfare (THL) (Finland)
Funders	Current information as of 22/12/2009:, Ministry of Health and Social Affairs (Finland) - National Institute for Health and Welfare (THL) and EVO-subsidies from Niuvanniemi Hospital, Initial information at time of registration:, 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

Submission date: 25/10/2007
Registration date: 30/10/2007
Last edited: 21/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jari Tiihonen
Scientific

Niuvanniemi Hospital
Kuopio
FI-70240
Finland

Phone	+ 358 (0)17 203 202
Email	jari.tiihonen@niuva.fi

Study information

Primary study design	Interventional
Study design	A parallel double-blind, randomised, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Naltrexone depot implant in the treatment of co-morbid amphetamine and opioid dependence: a double-blind, randomised, placebo-controlled trial
Study objectives	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(s)	Ethics approval received from the Independent Ethical Committee, St. Petersburg State Pavlov Medical University on the 24th September 2007 (ref: 84).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Naltrexone (Prodetoxone)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	28/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Total final enrolment	100
Key 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
Key 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
Date of first enrolment	01/03/2008
Date of final enrolment	28/02/2011

Locations

Countries of recruitment

Finland
Russian Federation

Study participating centre

Niuvanniemi Hospital

Kuopio
FI-70240
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012	21/08/2019	Yes	No

Editorial Notes

21/08/2019: Publication reference and total final enrolment added.