Back to resultsExtended Release Naltrexone for Treating Amphetamine Dependence in Iceland
Primary Purpose
Amphetamine Dependence
Status
Completed
Phase
Phase 3
Locations
Iceland
Study Type
Interventional
Intervention
VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Amphetamine Dependence focused on measuring amphetamine dependence, amphetamine injection, VIVITROL/VIVITROL placebo, amphetamine craving
Eligibility Criteria
Inclusion Criteria:
- Age 18 or above;
- Diagnosis of amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month, and patient and clinician identify amphetamine dependence as the main problem;
- Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines [unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo;
- Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly;
- Successfully complete 7-10 day assessment and study baseline measures at Vogur
Exclusion Criteria:
- Any liver test >5 times the top limit of normal; Physiologically dependent on opioids or other substances (nicotine excepted) at time of admission to Vogur;
- Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge:
- Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely depressed, suicidal or homicidal: Dementia: Inability to understand the informed consent;
- Planning to move from the Reykjavík area or enter jail within the next 12 months;
- Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure;
- Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG); carboxymethylcellulose, or any other component of the diluent;
- Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control;
- A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment;
- Use of an investigational agent in the past 30 days
Sites / Locations
- SAA National Center of Addiction Medicine, Vogur Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Extended release VIVITROL injection 380 mg, 24 weeks
VIVITROL placebo injection, 24 weeks
Arm Description
Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Outcomes
Primary Outcome Measures
Number Negative Urines (Proportion Negative Urines)
Number Negative Urines (Proportion Negative Urines) Amphetamine
Secondary Outcome Measures
Amphetamine Craving Scale
The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.
Beck Depression Inventory
The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.
Risk Assessment Battery
The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.
Prior Admissions to Vogur Hospital
Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.
Full Information
NCT ID
NCT01100853
First Posted
April 7, 2010
Last Updated
March 2, 2018
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA), Society of Alcoholism and other Addictions
1. Study Identification
Unique Protocol Identification Number
NCT01100853
Brief Title
Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
Official Title
Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA), Society of Alcoholism and other Addictions
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Dependence
Keywords
amphetamine dependence, amphetamine injection, VIVITROL/VIVITROL placebo, amphetamine craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended release VIVITROL injection 380 mg, 24 weeks
Arm Type
Active Comparator
Arm Description
Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Arm Title
VIVITROL placebo injection, 24 weeks
Arm Type
Placebo Comparator
Arm Description
Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Intervention Type
Drug
Intervention Name(s)
VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Intervention Description
Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Primary Outcome Measure Information:
Title
Number Negative Urines (Proportion Negative Urines)
Time Frame
24 Weeks
Title
Number Negative Urines (Proportion Negative Urines) Amphetamine
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Amphetamine Craving Scale
Description
The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.
Time Frame
24 weeks
Title
Beck Depression Inventory
Description
The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.
Time Frame
24 weeks
Title
Risk Assessment Battery
Description
The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.
Time Frame
24 weeks
Title
Prior Admissions to Vogur Hospital
Description
Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or above;
Diagnosis of amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month, and patient and clinician identify amphetamine dependence as the main problem;
Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines [unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo;
Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly;
Successfully complete 7-10 day assessment and study baseline measures at Vogur
Exclusion Criteria:
Any liver test >5 times the top limit of normal; Physiologically dependent on opioids or other substances (nicotine excepted) at time of admission to Vogur;
Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge:
Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely depressed, suicidal or homicidal: Dementia: Inability to understand the informed consent;
Planning to move from the Reykjavík area or enter jail within the next 12 months;
Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure;
Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG); carboxymethylcellulose, or any other component of the diluent;
Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control;
A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment;
Use of an investigational agent in the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Pettinati, Ph.D
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Woody, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAA National Center of Addiction Medicine, Vogur Hospital
City
Storhofda 45
State/Province
Reykjavík
ZIP/Postal Code
112
Country
Iceland
12. IPD Sharing Statement
Learn more about this trial
Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
We'll reach out to this number within 24 hrs