Cocaine DependencePhase 1NCT01030692
Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
A Phase 1 study testing Rivastigmine 3 mg, Huperzine A 0.4 mg and Rivastigmine 6 mg in people with Cocaine Dependence and Cocaine Addiction, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse
- What is being tested?
- Rivastigmine 3 mg, Huperzine A 0.4 mg and Rivastigmine 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be a cocaine-dependent volunteer who is non-treatment-seeking
- Meets DSM-IV criteria for cocaine dependence as determined by SCID, and has provided at least one cocaine-positive urine specimen within the 2 weeks prior to enrollment
- Be male or female, between 18 and 55 years old
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Female subjects must be non-nursing and postmenopausal, have had a hysterectomy, undergone tubal ligation, or have a negative pregnancy test and agree to use one of the birth control methods below
- Agreeable to conditions of the study and likely to complete schedule of interventions and measures
- Has medical history, physical exam, and screening laboratory results that demonstrate no contraindication to participation
Who cannot join
- Has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure
- Has a current psychiatric disorder other than cocaine abuse or dependence, including major depression, bipolar disorder, schizoaffective disorder, schizophrenia, organic brain disease, or dementia
- Meets DSM-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics
- Receiving opiate-substitution therapy (methadone, LAAM, or buprenorphine) within 2 mo's of enrollment
- Has a current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, febrile seizures, or family history of seizure disorder
- Has a diagnosis of adult (i.e., 21 years or older) asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral b-adrenergic agonist
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- Has had head trauma that resulted in neurological sequelae (e.g., loss of memory for greater than 5 min or that required hospitalization)
- Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, including, but not limited to, AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency (serum bilirubin or creatinine exceeding 1.5 the upper limit of normal, respectively)
- Be pregnant or lactating (nursing), or a fertile woman not practicing adequate methods of contraception or planning to become pregnant within one month of conclusion of the study
- Has current suicidal ideation or plan as assessed by SCID or MINI interview
- Has clinically significant ECG abnormalities, including QTc interval prolongation >450 ms in men or >480 ms in women
- In the opinion of the PI, be expected to fail to complete the study protocol due to probable incarceration or relocation from the clinic area
- Has clinically significant laboratory values (outside of normal limits), in the judgment of the PI
- Is on parole, probation or has any legal obligations
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.
Read the detailed description
The purpose of this study is to evaluate the interactions between cocaine and oral rivastigmine and between cocaine and oral huperzine A (HupA).
The following Specific Aims are proposed: 1. Among cocaine-dependent, non-treatment seeking participants, to establish the ability of rivastigmine (3 or 6 mg, daily) or HupA (0.4 or 0.8 mg, daily), as compared to placebo, to reduce cocaine-induced craving (0, 20, and 40 mg, IV) and to reduce reinforcing effects produced by cocaine (20 mg, IV/infusion). Hypothesis. Relative to placebo-treated participants, treatment with rivastigmine or HupA will reduce cocaine-induced craving and choices for cocaine.
- To determine the safety of rivastigmine and HupA in cocaine-dependent participants who receive cocaine in a laboratory setting. Hypothesis 2A. Relative to placebo-treated participants, treatment with rivastigmine or HupA will not increase the adverse events produced by cocaine. Hypothesis 2B. Relative to placebo-treated participants, treatment with rivastigmine or HupA will reduce cocaine-induced increases in heart rate and blood pressure.
- To determine the effects of AChE inhibition on plasma levels of cocaine and cocaine metabolites. Hypothesis 3A. Relative to placebo-treated participants, treatment with rivastigmine, but not HupA, will be associated with increased plasma levels of cocaine. Hypothesis 3B. Relative to placebo-treated participants, treatment with rivastigmine, but not HupA, will be associated with increased formation of ecgonine and benzoylecgonine, and decreased formation of ecgonine methylester.
- a) provide a more frequent measure of heart rate (15 sec vs. 5 minutes) and b) measure a new dependent variable, physical activity, on days with and without cocaine exposure.
Public Health Significance: Cocaine abuse is an important health problem that is associated with serious medical, psychiatric, social, and economic consequences. No medications are currently available for prevention of relapse in patients who are addicted to cocaine, and compounds such as rivastigmine and HupA are predicted to be useful for this indication. The testing of HupA is particularly exciting since it has antioxidant and neuroprotective properties that may also contribute to its efficacy as a treatment medication for cocaine dependence.
- Conditions
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Substance Abuse
- Being tested
- Placebo, Rivastigmine 3 mg, Huperzine A 0.4 mg, Rivastigmine 6 mg, Huperzine A 0.8 mg
- Keywords
- Cocaine, Rivastigmine, Huperzine A
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar pill
The placebo groups will receive the same dosage throughout the study.
Rivastigmine 3 mgDrug
Also called Exelon
The 3 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-9, and 3 mg in the morning of Day 10.
Huperzine A 0.4 mgDrug
Also called Huperzine
The 0.4 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-9, and 0.2 mg in the morning of day 10.
Rivastigmine 6 mgDrug
Also called Exelon
The 6 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-5, 3 mg in the morning and evening of Days 6-9, and 3 mg in the morning of Day 10.
Huperzine A 0.8 mgDrug
Also called Huperzine
The 0.8 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-5, 0.4 mg in the morning and evening of Days 6-9, and 0.4 mg in the morning of Day 10.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules as control Receives: Drug: Placebo |
| Rivastigmine 3 mg | Active comparator | Rivastigmine 3 mg Receives: Drug: Rivastigmine 3 mg |
| Rivastigmine 6 mg | Active comparator | Rivastigmine 6 mg Receives: Drug: Rivastigmine 6 mg |
| Huperzine A 0.4 mg | Active comparator | Huperzine A 0.4 mg Receives: Drug: Huperzine A 0.4 mg |
| Huperzine A 0.8 mg | Active comparator | Huperzine A 0.8 mg Receives: Drug: Huperzine A 0.8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of rivastigmine or huperzine A and cocaine on cardiovascular measures
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on rivastigmine or HupA relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
Measured: 10 days
Secondary outcomes (1)
The effects of rivastigmine or huperzine A and cocaine on subjective measures
The ability of rivastigmine (3 or 6 mg, daily) or HupA (0.4 or 0.8 mg, daily), as compared to placebo, to reduce cocaine-induced craving (0, 20, and 40 mg, IV) and to reduce reinforcing effects produced by cocaine (20 mg, IV/infusion) will be measured by: 1. VAS, Adjective Scales, and MCQ; 2. Choices for cocaine vs. money in the self-administration assay.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
- Investigators
- Richard De La Garza, II, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030692
- Sponsor's protocol ID
- H-24716
- Other IDs
- 1R01DA023624, DPMC
- Status last verified
- Jan 2015
- First submitted
- 10 Dec 2009
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01030692
- Acronym / sponsor ID
- H-24716
- Conditions
- Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Substance Abuse
- Keywords
- Cocaine, Rivastigmine, Huperzine A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Dec 2009 (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.
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.
Detailed description
The purpose of this study is to evaluate the interactions between cocaine and oral rivastigmine and between cocaine and oral huperzine A (HupA).
The following Specific Aims are proposed: 1. Among cocaine-dependent, non-treatment seeking participants, to establish the ability of rivastigmine (3 or 6 mg, daily) or HupA (0.4 or 0.8 mg, daily), as compared to placebo, to reduce cocaine-induced craving (0, 20, and 40 mg, IV) and to reduce reinforcing effects produced by cocaine (20 mg, IV/infusion). Hypothesis. Relative to placebo-treated participants, treatment with rivastigmine or HupA will reduce cocaine-induced craving and choices for cocaine.
- To determine the safety of rivastigmine and HupA in cocaine-dependent participants who receive cocaine in a laboratory setting. Hypothesis 2A. Relative to placebo-treated participants, treatment with rivastigmine or HupA will not increase the adverse events produced by cocaine. Hypothesis 2B. Relative to placebo-treated participants, treatment with rivastigmine or HupA will reduce cocaine-induced increases in heart rate and blood pressure.
- To determine the effects of AChE inhibition on plasma levels of cocaine and cocaine metabolites. Hypothesis 3A. Relative to placebo-treated participants, treatment with rivastigmine, but not HupA, will be associated with increased plasma levels of cocaine. Hypothesis 3B. Relative to placebo-treated participants, treatment with rivastigmine, but not HupA, will be associated with increased formation of ecgonine and benzoylecgonine, and decreased formation of ecgonine methylester.
- a) provide a more frequent measure of heart rate (15 sec vs. 5 minutes) and b) measure a new dependent variable, physical activity, on days with and without cocaine exposure.
Public Health Significance: Cocaine abuse is an important health problem that is associated with serious medical, psychiatric, social, and economic consequences. No medications are currently available for prevention of relapse in patients who are addicted to cocaine, and compounds such as rivastigmine and HupA are predicted to be useful for this indication. The testing of HupA is particularly exciting since it has antioxidant and neuroprotective properties that may also contribute to its efficacy as a treatment medication for cocaine dependence.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules as control |
| Rivastigmine 3 mg | Active comparator | Drug: Rivastigmine 3 mgRivastigmine 3 mg |
| Rivastigmine 6 mg | Active comparator | Drug: Rivastigmine 6 mgRivastigmine 6 mg |
| Huperzine A 0.4 mg | Active comparator | Drug: Huperzine A 0.4 mgHuperzine A 0.4 mg |
| Huperzine A 0.8 mg | Active comparator | Drug: Huperzine A 0.8 mgHuperzine A 0.8 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be a cocaine-dependent volunteer who is non-treatment-seeking
- Meets DSM-IV criteria for cocaine dependence as determined by SCID, and has provided at least one cocaine-positive urine specimen within the 2 weeks prior to enrollment
- Be male or female, between 18 and 55 years old
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Female subjects must be non-nursing and postmenopausal, have had a hysterectomy, undergone tubal ligation, or have a negative pregnancy test and agree to use one of the birth control methods below
Key exclusion criteria (14 listed)
- Has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure
- Has a current psychiatric disorder other than cocaine abuse or dependence, including major depression, bipolar disorder, schizoaffective disorder, schizophrenia, organic brain disease, or dementia
- Meets DSM-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics
- Receiving opiate-substitution therapy (methadone, LAAM, or buprenorphine) within 2 mo's of enrollment
- Has a current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, febrile seizures, or family history of seizure disorder
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 |
|---|---|---|
| PlaceboAlso: Sugar pillThe placebo groups will receive the same dosage throughout the study. | Drug | Placebo |
| Rivastigmine 3 mgAlso: ExelonThe 3 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-9, and 3 mg in the morning of Day 10. | Drug | Rivastigmine 3 mg |
| Huperzine A 0.4 mgAlso: HuperzineThe 0.4 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-9, and 0.2 mg in the morning of day 10. | Drug | Huperzine A 0.4 mg |
| Rivastigmine 6 mgAlso: ExelonThe 6 mg rivastigmine group will receive 3 mg rivastigmine only in the evening of Day 1, 3 mg in the morning and 0 mg in the evening of Days 2-5, 3 mg in the morning and evening of Days 6-9, and 3 mg in the morning of Day 10. | Drug | Rivastigmine 6 mg |
| Huperzine A 0.8 mgAlso: HuperzineThe 0.8 mg HupA group will receive 0.2 mg HupA only in the evening of Day 1, 0.2 mg in the morning and evening of Days 2-5, 0.4 mg in the morning and evening of Days 6-9, and 0.4 mg in the morning of Day 10. | Drug | Huperzine A 0.8 mg |
Primary outcome
The effects of rivastigmine or huperzine A and cocaine on cardiovascular measures
Time frame: 10 days
Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on rivastigmine or HupA relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
1 secondary outcome
The effects of rivastigmine or huperzine A and cocaine on subjective measures
Time frame: 10 days
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 27 Jan 2015.
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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.
Richard De La Garza, II, PhD principal investigator
Baylor College of Medicine
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 Rivastigmine 3 mg, Huperzine A 0.4 mg and Rivastigmine 6 mg in people with Cocaine Dependence and Cocaine Addiction, run by Baylor College of Medicine 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 7 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 27 Jan 2015. 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?
The effects of rivastigmine or huperzine A and cocaine on cardiovascular measures (time frame: 10 days). 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 27 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.