Amphetamine DependencePhase 3NCT01100853
Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
A Phase 3 study of Amphetamine Dependence, run by University of Pennsylvania at 1 site in Iceland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amphetamine Dependence
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIceland
- Study dates
- May 2010to Feb 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Iceland1 site
SAA National Center of Addiction Medicine, Vogur Hospital
Storhofda 45, Reykjavík, 112
About this study
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.
- Conditions
- Amphetamine Dependence
- Being tested
- VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
- Keywords
- amphetamine dependence, amphetamine injection, VIVITROL/VIVITROL placebo, amphetamine craving
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITROL injection and VIVITROL Placebo Injection , 24 weeksDrug
Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
| Study group | Role | What they receive |
|---|---|---|
| Extended release VIVITROL injection 380 mg, 24 weeks | Active comparator | 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) Receives: Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks |
| VIVITROL placebo injection, 24 weeks | Placebo comparator | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) Receives: Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Negative Urines (Proportion Negative Urines)
Measured: 24 Weeks
Number Negative Urines (Proportion Negative Urines) Amphetamine
Measured: 24 weeks
Secondary outcomes (4)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amphetamine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Society of Alcoholism and other Addictions
- Responsible party
- Sponsor
- Investigators
- Helen Pettinati, Ph.D, Principal investigator, University of PennsylvaniaGeorge Woody, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100853
- Sponsor's protocol ID
- 811095
- Other IDs
- P50DA012756, 2009-013647-10, 2009
- Status last verified
- Mar 2018
- First submitted
- 7 Apr 2010
- Last updated
- 6 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland
- ClinicalTrials.gov ID
- NCT01100853
- Acronym / sponsor ID
- 811095
- Conditions
- Amphetamine Dependence
- Keywords
- amphetamine dependence, amphetamine injection, VIVITROL/VIVITROL placebo, amphetamine craving
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Society of Alcoholism and other Addictions
- Study start
- May 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended release VIVITROL injection 380 mg, 24 weeks | Active comparator | Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeksEfficacy 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) |
| VIVITROL placebo injection, 24 weeks | Placebo comparator | Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeksEfficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVITROL injection and VIVITROL Placebo Injection , 24 weeksEfficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | Drug | Extended release VIVITROL injection 380 mg, 24 weeks, VIVITROL placebo injection, 24 weeks |
Primary outcome
Number Negative Urines (Proportion Negative Urines)
Time frame: 24 Weeks
Number Negative Urines (Proportion Negative Urines) Amphetamine
Time frame: 24 weeks
4 secondary outcomes
Amphetamine Craving Scale
Time frame: 24 weeks
Beck Depression Inventory
Time frame: 24 weeks
Risk Assessment Battery
Time frame: 24 weeks
Prior Admissions to Vogur Hospital
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Pettinati, Ph.D principal investigator
University of Pennsylvania
George Woody, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Amphetamine Dependence, run by University of Pennsylvania at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Negative Urines (Proportion Negative Urines) (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.