Cocaine DependencePhase 1/2VyvanceNCT01486810
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
A Phase 1/2 study testing Lisdexamfetamine and medication management in people with Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Lisdexamfetamine and medication management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals must be treatment seeking
- Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence
- Used cocaine at least four days in the past month
- Individuals must be in good general health
- Individuals must be capable of giving informed consent and capable of complying with study procedures
- Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.
Who cannot join
- Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, any psychotic disorder other than transient psychosis due to drug abuse, or current major depressive disorder
- Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
- Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
- Individuals with current suicidal risk
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
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- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 1.5x upper limit of normal are acceptable), or uncontrolled diabetes
- Individuals with a history of seizures, hyperthyroidism and/or glaucoma
- Individuals with a family history of sudden cardiac death
- History of allergic reaction to study medication
- Women who are pregnant or nursing
- Currently being prescribed psychotropic medication by another physician (other than sleep medication)
- Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
Trial locations and contacts
1 site in 1 country.
About this study
The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.
Read the detailed description
In an eight-week open label outpatient pilot trial, we will evaluate the safety, tolerability, and potential utility of LDX in the treatment of cocaine dependence. Patients will receive a flexible-fixed dosing schedule under open-label conditions. Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks, followed by a two week run-down period. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
The primary outcome measures will be 1) the maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period 2) lisdexamfetamine tolerability as measured by adverse effects reported on the Systematic Assessment for Treatment and Emergent Events (SAFTEE). Secondary outcome measures will be 1) cocaine use as recorded by the number of days of use on the Timeline Follow-Back method (Sobell \& Sobell, 1992) and confirmed by urine toxicology, 2) cocaine craving as measured by the Cocaine Craving Scale (CCS) and Cocaine Craving Questionnaire (CCQ) and 3) alternate measures of cocaine use, such as the dollar value of cocaine used per day, as measured by the Timeline Follow-Back method, and the proportion of urine toxicology samples negative for cocaine.
- Conditions
- Cocaine Dependence
- Being tested
- Lisdexamfetamine, medication management
- Keywords
- cocaine, lisdexamfetamine
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisdexamfetamineDrug
Also called Vyvance
Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
medication managementBehavioural
All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
| Study group | Role | What they receive |
|---|---|---|
| Lisdexamfetamine and medication management | Experimental | Patients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders. Receives: Drug: Lisdexamfetamine; Behavioral: medication management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Measured: during 1 week of study participation
Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Measured: during 8 weeks of trial or length of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 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 Cocaine DependenceStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, John Mariani MD, New York State Psychiatric Institute
- Investigators
- John Mariani, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486810
- Sponsor's protocol ID
- #6154
- Other IDs
- P50DA009236-18
- Acronym
- Vyvance
- Status last verified
- Apr 2019
- First submitted
- 30 Nov 2011
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01486810
- Acronym / sponsor ID
- Vyvance / #6154
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, lisdexamfetamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.
Detailed description
In an eight-week open label outpatient pilot trial, we will evaluate the safety, tolerability, and potential utility of LDX in the treatment of cocaine dependence. Patients will receive a flexible-fixed dosing schedule under open-label conditions. Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks, followed by a two week run-down period. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
The primary outcome measures will be 1) the maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period 2) lisdexamfetamine tolerability as measured by adverse effects reported on the Systematic Assessment for Treatment and Emergent Events (SAFTEE). Secondary outcome measures will be 1) cocaine use as recorded by the number of days of use on the Timeline Follow-Back method (Sobell \& Sobell, 1992) and confirmed by urine toxicology, 2) cocaine craving as measured by the Cocaine Craving Scale (CCS) and Cocaine Craving Questionnaire (CCQ) and 3) alternate measures of cocaine use, such as the dollar value of cocaine used per day, as measured by the Timeline Follow-Back method, and the proportion of urine toxicology samples negative for cocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lisdexamfetamine and medication management | Experimental | Drug: Lisdexamfetamine, Behavioral: medication managementPatients will be titrated to the tolerated dose of Lisdexamfetamine over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks. All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Individuals must be treatment seeking
- Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence
- Used cocaine at least four days in the past month
- Individuals must be in good general health
- Individuals must be capable of giving informed consent and capable of complying with study procedures
Key exclusion criteria (13 listed)
- Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, any psychotic disorder other than transient psychosis due to drug abuse, or current major depressive disorder
- Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
- Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
- Individuals with current suicidal risk
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 |
|---|---|---|
| LisdexamfetamineAlso: VyvancePatients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks | Drug | Lisdexamfetamine and medication management |
| medication managementAll participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders. | Behavioural | Lisdexamfetamine and medication management |
Primary outcome
Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.
Time frame: during 1 week of study participation
Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..
Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.
Time frame: during 8 weeks of trial or length of participation
The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Mariani, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lisdexamfetamine and medication management in people with Cocaine Dependence, run by New York State Psychiatric Institute 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 13 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 24 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Jul 2018). 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 of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. (time frame: during 1 week of study participation). 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 24 Apr 2019.