Rivastigmine as a Treatment for Methamphetamine Dependence

NCT01073319 | Completed Phase 1 DMC

• 3 other identifiers: H-23064R01DA023964DPMC
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effects of treatment with rivastigmine on craving produced by experimental administration of methamphetamine.

Conditions

Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse

Keywords

Methamphetamine; Rivastigmine

Outcome Measures

Primary Outcomes (1)

• Effects of rivastigmine and methamphetamine on cardiovascular measures

  Beginning with intake, vital signs (temperature with orthostatic BP and HR) will be recorded every 8 hours. Before and after the intravenous METH infusion, subjects' physiologic responses will be closely monitored using repeated HR, BP, and ECG readings.

Secondary Outcomes (1)

• Effects of rivastigmine and methamphetamine on subjective measures (craving and choices for METH)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching oral placebo capsule as control.

Other: Placebo

Rivastigmine 3 mg

ACTIVE COMPARATOR

Drug: Rivastigmine

Rivastigmine 6 mg

ACTIVE COMPARATOR

Drug: Rivastigmine

Interventions

Placebo OTHER

Administration of placebo pill

Also known as: Sugar pill

Placebo

Rivastigmine DRUG

Participants will be randomized to rivastigmine (1.5 mg bid) for 6 days of each phase.

Also known as: Exelon

Rivastigmine 3 mg

Eligibility Criteria

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

You may qualify if:

• Be English-speaking volunteers who are not seeking abstinence-focused treatment at the time of the study
• Be between 18-55 years of age
• Meet DSM-IV-TR criteria for METH dependence
• Self-report that preferred route of METH use is intravenous or smoke
• Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 85-150 mmHg systolic and 45-90 mmHg diastolic
• Have a breathalyzer test indicating an undetectable blood alcohol level upon admission
• Have hematology and chemistry laboratory tests that are within normal ("b10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) \< 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) \< 2 x the upper limit of normal
• Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias
• Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician/ Nurse Practitioner (or Advanced Practice Nurse) and the PI
• Weigh between 60 and 100 kg
• Have a negative urine drug screen, with the exception of methamphetamine or marijuana

You may not qualify if:

• Have any previous medically adverse reaction to METH, including loss of consciousness, chest pain, or epileptic seizure
• Have neurological or psychiatric disorders, as assessed by MINI, such as: a. episode of major depression within the past 2 years; b. lifetime history of schizophrenia, other psychotic illness, or bipolar illness; c. current organic brain disease or dementia assessed by clinical interview; d. history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; e. history of suicide attempts within the past three months and/or current suicidal ideation/plan; and f. history of psychosis occurring in the absence of current METH use
• Meet DSM-IV criteria for dependence on alcohol or other drugs, except for nicotine or marijuana
• Have evidence of clinically significant heart disease or hypertension as determined by the admitting physician/NP/APN
• Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
• Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication
• Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, and weekly throughout the study
• Have any history of asthma, chronic coughing and wheezing, or other chronic respiratory illnesses
• Currently use alpha or beta agonists, theophylline, or other sympathomimetics
• Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician/NP/APN would preclude safe and/or successful completion of study.
• Criteria for Discontinuation Following Initiation:
• Participants will be discharged if they have a positive breath test indicating use of alcohol or a urine test indicating illicit use of drugs while in the GCRC, if they do not comply with study procedures, or if they do not tolerate METH. All female subjects of child bearing potential will be tested for pregnancy at each admission and those with positive test results will be discharged.

Sponsors & Collaborators

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

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Sugars; Rivastigmine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 23, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

US (1)