NCT01406522

Brief Summary

No medications are currently available for treatment of psychostimulant addiction, a compulsive preoccupation with use of cocaine and related compounds. Tacrine, a medication that is currently prescribed for Alzheimer's disease, can decrease the amount of cocaine injections that laboratory animals choose to inject by vein. This project will determine if tacrine can also decrease cocaine-motivated behavior for human subjects in a laboratory setting.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

July 28, 2011

Last Update Submit

December 17, 2013

Conditions

Cocaine Dependence

Keywords

AcetylcholineCholinesterasesCocaineSelf-Administration

Outcome Measures

Primary Outcomes (1)

  • Decreased cocaine-reinforced behavior

    participants will make a series of choices between vouchers with an ascending monetary value and intravenous injections of cocaine

    Day 9 of treatment

Secondary Outcomes (1)

  • Changes in cocaine pharmacokinetics

    Day 9 of treatment

Study Arms (2)

Oral placebo

PLACEBO COMPARATOR

Inactive treatment

Drug: Oral placebo

Oral tacrine

EXPERIMENTAL

Oral tacrine

Drug: Oral tacrine

Interventions

Oral tacrineDRUG

Tacrine, 160 mg per day, four times daily

Oral tacrine
Oral placeboDRUG

Microcrystalline cellulose

Oral placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV-TR criteria for cocaine abuse or dependence, with at least one cocaine-positive urine specimen within the six weeks prior to enrollment.
  • Has used cocaine for a duration of at least 6 months, with at least weekly use during the last 30 days by a rapid route of administration (either smoked or intravenous injection).
  • Is male or female, between 21 and 50 years old.

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 any current Axis I psychiatric disorder other than drug abuse or dependence.
  • Meets DSM-IV-TR criteria for dependence on opiates, benzodiazepines, alcohol, or other sedative-hypnotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (2)

  • Grasing K, He S, Yang Y. Dose-related effects of the acetylcholinesterase inhibitor tacrine on cocaine and food self-administration in rats. Psychopharmacology (Berl). 2008 Jan;196(1):133-42. doi: 10.1007/s00213-007-0944-3. Epub 2007 Oct 5.

    PMID: 17917719BACKGROUND

  • Grasing K, He S, Yang Y. Long-lasting decreases in cocaine-reinforced behavior following treatment with the cholinesterase inhibitor tacrine in rats selectively bred for drug self-administration. Pharmacol Biochem Behav. 2009 Nov;94(1):169-78. doi: 10.1016/j.pbb.2009.08.004. Epub 2009 Aug 19.

    PMID: 19698738BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Tacrine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kenneth W Grasing, M.D.

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Substance Abuse Research Laboratory

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

October 1, 2012

Primary Completion

September 1, 2013

Study Completion

November 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

US(1)