A Pilot Study of Cabergoline for the Treatment of Cocaine Dependence

NCT01651364 | Completed Phase 1 DMC

• 3 other identifiers: H-27036DPMC2630090202
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of treatment with cabergoline, compared to treatment with placebo, on cocaine induced craving and subjective effects in cocaine-dependent human volunteers.

Conditions

Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse

Keywords

Cocaine; Cabergoline

Outcome Measures

Primary Outcomes (1)

• The effects of treatment with cabergoline 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 cabergoline relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.

Secondary Outcomes (1)

• The effects of treatment with cabergoline and cocaine on cocaine-induced craving and subjective effects

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Cabergoline

ACTIVE COMPARATOR

Drug: Cabergoline

Interventions

Placebo DRUG

Enrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator.

Also known as: Sugar pill

Placebo

Cabergoline DRUG

Enrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly.

Also known as: Dostinex, Cabaser

Cabergoline

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 treatment at the time of the study.
• Be between 18-55 years of age.
• Meet DSM-IV TR criteria for cocaine dependence; participants may or may not meet criteria for nicotine dependence. Nicotine dependence is allowed but not required because most cocaine users smoke cigarettes.
• Have a self-reported history of using cocaine by the smoked or IV route.
• Have vital signs as follows: supine blood pressure \> 100/65 mm Hg. To ensure that subjects will not be at risk from cocaine, the resting pulse must be \< 90 bpm and the blood pressure must be \< 150 mmHg systolic and \< 90 mmHg diastolic.
• Have hematology and chemistry laboratory tests that are within normal (+/- 10%) 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) within normal limits.
• Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically 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 and the principal investigator.
• Females must have a negative urine pregnancy test during screening and at followup, on day 22.
• Provide a negative urine test for cocaine metabolite on Day 1.

You may not qualify if:

• Meet DSM IV TR criteria for dependence on drugs other than cocaine or nicotine.
• Have any history or evidence suggestive of seizure disorder or brain injury.
• Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure.
• Have a history of heart valve disease.
• Have any evidence from physical exam of heart murmur.
• Have neurological or psychiatric disorders, such as: psychosis, bipolar illness or major depression as assessed by MINI; organic brain disease or dementia assessed by clinical interview; history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past year and/or current suicidal ideation/plan.
• Have evidence of clinically significant heart disease or hypertension, as determined by the PI.
• Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.
• Have symptomatic HIV or are taking 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, upon hospital admission, and at the end of study participation.
• Have asthma or currently use theophylline or other sympathomimetics.
• Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
• Criteria for Discontinuation Following Initiation:
• Inability to comply with study procedures.
• Meet discontinuation criteria due to exaggerated response to cocaine, described below.

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

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Sugars; Cabergoline

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

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: Professor

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

US (1)