Methamphetamine DependencePhase 1NCT02034201
Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence
A Phase 1 study testing Lisdexamfetamine in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
Trial summary
Methamphetamine dependence is a serious public health problem, with methamphetamine abusers being at risk for significant morbidity and mortality, including HIV. To date, no medication or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 19 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65 yrs).
- Participants must fulfill DSM-IV criteria for Methamphetamine dependence These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on clinical assessments and the patient will also need to meet criteria for methamphetamine dependence based on administration of the SCID.
- Self-reported average METH use of at least 250 mg of methamphetamine per occasion at least once weekly during the preceding 3-month period.
- A positive urine toxicology screen for methamphetamine. Participants must submit a urine sample negative for drugs of abuse (opiates, benzodiazepines, cocaine and PCP) other than methamphetamine or marijuana during the week prior to starting the study.
- Women of child-bearing potential will be included provided they 1) have a negative pregnancy test, 2) agree to adequate contraception (tubal ligation, hysterectomy, barrier contraceptive method or oral contraceptive method) to prevent pregnancy during the study and 3) are not nursing.
- Normal blood pressure with SBP >89 and < 141, DBP >59 and < 91.
Who cannot join
- Current suicidality or psychosis
- Current cocaine dependence or opioid, alcohol, or sedative physical dependence
- Major hepatic or cardiovascular disorder (including history of myocardial infarction, cardiovascular disease, or history of or currently clinically significant ECG abnormality) or unstable medical condition that contraindicates study participation
- History of schizophrenia or bipolar type I disorder
- Use of medications that would be expected to have major interaction with LDX including psychotropics
- Medical contraindication to receiving LDX
Show all 14Show fewer
- Positive drug screen for cocaine, opiates, sedatives or PCP.
- History of Seizure disorder
- Documented hypersensitivity to sympathomimetic amines
- LFT >3xULN
- Pregnancy/nursing
- Current use or past 2 weeks use of MAOi
- History of Narrow-angle glaucoma
- g.n. History of Hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Methamphetamine dependence is a serious public health problem, with methamphetamine abusers being at risk for significant morbidity and mortality, including HIV. To date, no medication or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder. This clinical trial will examine whether lisdexamfetamine shows promise in alleviating withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent methamphetamine dependent individuals. Findings of this study will not only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but also inform future medication development strategies for improving treatment for drug dependence disorders. Discovering efficacious limited risk interventions that show more robust, longer-term outcomes would be beneficial both to the individual and society.
- Conditions
- Methamphetamine Dependence
- Being tested
- Lisdexamfetamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisdexamfetamineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine | Active comparator | Lisdexamfetamine will be admistered at 140 mg orally daily through week 6 of the protocol. Receives: Drug: Lisdexamfetamine |
| Placebo | Placebo comparator | Placebo will be administered orally daily through week 6 of the protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that relapse to methamphetamine use.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion19 May 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034201
- Sponsor's protocol ID
- 119273
- Other IDs
- R21DA034824-01A1
- Status last verified
- Aug 2017
- First submitted
- 9 Jan 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT02034201
- Acronym / sponsor ID
- 119273
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2014
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methamphetamine dependence is a serious public health problem, with methamphetamine abusers being at risk for significant morbidity and mortality, including HIV. To date, no medication or psychotherapeutic strategy has shown robust, long-term efficacy in treating this disorder. This clinical trial will examine whether lisdexamfetamine shows promise in alleviating withdrawal symptoms and preventing relapse relative to placebo in recently-abstinent methamphetamine dependent individuals. Findings of this study will not only shed light on whether lisdexamfetamine may improve upon treatment for this disorder but also inform future medication development strategies for improving treatment for drug dependence disorders. Discovering efficacious limited risk interventions that show more robust, longer-term outcomes would be beneficial both to the individual and society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine | Active comparator | Drug: LisdexamfetamineLisdexamfetamine will be admistered at 140 mg orally daily through week 6 of the protocol. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered orally daily through week 6 of the protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age (18-65 yrs).
- Participants must fulfill DSM-IV criteria for Methamphetamine dependence These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on clinical assessments and the patient will also need to meet criteria for methamphetamine dependence based on administration of the SCID.
- Self-reported average METH use of at least 250 mg of methamphetamine per occasion at least once weekly during the preceding 3-month period.
- A positive urine toxicology screen for methamphetamine. Participants must submit a urine sample negative for drugs of abuse (opiates, benzodiazepines, cocaine and PCP) other than methamphetamine or marijuana during the week prior to starting the study.
- Women of child-bearing potential will be included provided they 1) have a negative pregnancy test, 2) agree to adequate contraception (tubal ligation, hysterectomy, barrier contraceptive method or oral contraceptive method) to prevent pregnancy during the study and 3) are not nursing.
Key exclusion criteria (14 listed)
- Current suicidality or psychosis
- Current cocaine dependence or opioid, alcohol, or sedative physical dependence
- Major hepatic or cardiovascular disorder (including history of myocardial infarction, cardiovascular disease, or history of or currently clinically significant ECG abnormality) or unstable medical condition that contraindicates study participation
- History of schizophrenia or bipolar type I disorder
- Use of medications that would be expected to have major interaction with LDX including psychotropics
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 |
|---|---|---|
| Lisdexamfetamine | Drug | Lisdexamfetamine |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of participants that relapse to methamphetamine use.
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lisdexamfetamine in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
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 6 inclusion and 14 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 22 Aug 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants that relapse to methamphetamine use. (time frame: 9 weeks). 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 22 Aug 2017.