Impulsivity and Stimulant Administration

NCT01978431 | Completed Phase 1

• 2 other identifiers: 1001006250R25MH071584
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Examine the interaction between stimulants, such as cocaine and methylphenidate, and impulsivity.

Conditions

Cocaine Dependence; Impulsivity

Outcome Measures

Primary Outcomes (1)

• Mean cocaine inter-infusion interval

  Subjects complete three separate 60 minute long "binge" cocaine self administration sessions (low dose 8mg/70kg, medium dose 16mg/70kg, and large dose 32mg/70kg). Mean inter-infusion intervals (time between cocaine boluses) are then averaged by adding all intervals within each session and dividing by 60. Intervals during which pump access is withheld (due to increase in vital signs) will be excluded. Data on cocaine self-administration (total number of responses, infusions, and III), subjective effects, and vital signs will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. The significance level for all statistical tests will be set at p\<.05.

  3 hours

Secondary Outcomes (2)

• Stop Signal Reaction Time (Impulsivity)

  5 years

• Inter-Temporal Choice (Impulsivity)

  5 years

Study Arms (2)

Stimulant

EXPERIMENTAL

Cocaine and Methylphenidate

Drug: cocaine hydrochloride; Drug: methylphenidate

Placebo

PLACEBO COMPARATOR

methylphenidate

Drug: methylphenidate

Interventions

cocaine hydrochloride DRUG

Stimulant

methylphenidate DRUG

Placebo; Stimulant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 - 50 years,
• voluntary, written, informed consent,
• physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
• DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
• recent street cocaine use in excess of amounts to be administered in the current study,
• intravenous and/or smoked (crack/ freebase) use,
• positive urine toxicology screen for cocaine,
• for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.

You may not qualify if:

• Other drug dependence (except nicotine) as determined by urine toxicology or interview
• \< 1 year of cocaine dependence,
• a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
• a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
• current use of psychotropic and/or potentially psychoactive prescription medication,
• seeking treatment for drug abuse/dependence (for experimental cocaine component),
• physical or laboratory (β-HCG) evidence of pregnancy.
• current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• Kohler RJ, Zhornitsky S, Potenza MN, Yip SW, Worhunsky P, Angarita GA. Cocaine self-administration behavior is associated with subcortical and cortical morphometry measures in individuals with cocaine use disorder. Am J Drug Alcohol Abuse. 2024 May 3;50(3):345-356. doi: 10.1080/00952990.2024.2318585. Epub 2024 Mar 29.

  PMID: 38551365 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Impulsive Behavior

Interventions

Cocaine; Methylphenidate

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

US (1)