Rivastigmine and Huperzine A as Treatments for Cocaine Dependence

NCT01030692 | Completed Phase 1 DMC

• 3 other identifiers: H-247161R01DA023624DPMC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Substance Abuse

Keywords

Cocaine; Rivastigmine; Huperzine A

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days

Secondary Outcomes (1)

• The effects of rivastigmine or huperzine A and cocaine on subjective measures

  10 days

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo capsules as control

Drug: Placebo

Rivastigmine 3 mg

ACTIVE COMPARATOR

Rivastigmine 3 mg

Drug: Rivastigmine 3 mg

Rivastigmine 6 mg

ACTIVE COMPARATOR

Rivastigmine 6 mg

Drug: Rivastigmine 6 mg

Huperzine A 0.4 mg

ACTIVE COMPARATOR

Huperzine A 0.4 mg

Drug: Huperzine A 0.4 mg

Huperzine A 0.8 mg

ACTIVE COMPARATOR

Huperzine A 0.8 mg

Drug: Huperzine A 0.8 mg

Interventions

Placebo DRUG

The placebo groups will receive the same dosage throughout the study.

Also known as: Sugar pill

Placebo

Rivastigmine 3 mg DRUG

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.

Also known as: Exelon

Rivastigmine 3 mg

Huperzine A 0.4 mg DRUG

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.

Also known as: Huperzine

Huperzine A 0.4 mg

Rivastigmine 6 mg DRUG

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.

Also known as: Exelon

Rivastigmine 6 mg

Huperzine A 0.8 mg DRUG

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.

Also known as: Huperzine

Huperzine A 0.8 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Sugars; Rivastigmine; huperzine A

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Richard De La Garza, II, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

US (1)