NCT00958282

Brief Summary

This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

August 1, 2015

Enrollment Period

3.5 years

First QC Date

August 12, 2009

Results QC Date

June 11, 2015

Last Update Submit

August 13, 2015

Conditions

Cocaine Dependence

Keywords

cocainetreatmentlisdexamfetaminedependenceaddictioncrack

Outcome Measures

Primary Outcomes (1)

  • Cocaine-positive Urine Results

    At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.

    14 Weeks

Secondary Outcomes (1)

  • Drug Craving

    14 Weeks

Study Arms (2)

lisdexamfetamine/Behavior Therapy

ACTIVE COMPARATOR

lisdexamfetamine 70mg/day plus Behavior Therapy

Drug: lisdexamfetamine/Behavior Therapy

placebo

PLACEBO COMPARATOR

Placebo Comparator once per day

Other: placebo

Interventions

lisdexamfetamine/Behavior TherapyDRUG
lisdexamfetamine/Behavior Therapy
placeboOTHER
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants must:
  • Be treatment-seeking males or females between 18 and 65 years-of-age;
  • Understand the study procedures and provide written informed consent;
  • Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
  • Meet DSM-IV criteria for cocaine-dependence.

You may not qualify if:

  • DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
  • Current use of any prescription medications;
  • Females currently pregnant or nursing;
  • Current elevation of liver enzyme levels above twice normal limits;
  • Existing cardiovascular disease as determined by physician, EKG evaluation;
  • History of significant acute or chronic physical illness precluding participation;
  • History of hyperthyroidism, glaucoma, or seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatory Research Center/Fairview University Psychiatry Dept

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersBehavior, Addictive

Interventions

Lisdexamfetamine DimesylateBehavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Marc Mooney
Organization
University of Minnesota
moon0078@umn.edu
6129916875

Study Officials

  • Marc Mooney, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

September 17, 2015

Results First Posted

September 17, 2015

Record last verified: 2015-08

Locations

US(1)