Condition category
Mental and Behavioural Disorders
Date applied
25/10/2007
Date assigned
30/10/2007
Last edited
22/12/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

http://www.thl.fi

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes