NCT00218036

Brief Summary

The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

November 16, 2018

Completed
Last Updated

November 16, 2018

Status Verified

October 1, 2018

Enrollment Period

3.6 years

First QC Date

September 16, 2005

Results QC Date

May 1, 2018

Last Update Submit

October 19, 2018

Conditions

Cocaine AbuseOpiate Dependence

Keywords

Cocaine AbuseOpiate Abuse

Outcome Measures

Primary Outcomes (1)

  • Confirmed Abstinence From Cocaine

    12 weeks of treatment

Secondary Outcomes (2)

  • Retention

    12 weeks of treatment

  • Medication Compliance

    12 weeks of treatment

Study Arms (5)

1

EXPERIMENTAL

Modafinil 200mg / Methadone Maintenance (1.2mg/kg)

Drug: Modafinil 200mg

2

EXPERIMENTAL

Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)

Drug: Modafinil 400mg

3

EXPERIMENTAL

Citalopram 20/ Methadone Maintenance 1.2mg/kg

Drug: Citalopram 20mg

4

EXPERIMENTAL

Citalopram 40/ Methadone Maintenance 1.2 mg/kg

Drug: Citalopram 40mg

5

PLACEBO COMPARATOR

Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study

Drug: Placebo

Interventions

Modafinil 200mgDRUG

10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.

1
Modafinil 400mgDRUG

10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.

2
Citalopram 20mgDRUG

10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.

3
Citalopram 40mgDRUG

10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.

4
PlaceboDRUG

Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

5

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Meets cocaine abuse and dependence criteria (as determined by the SCID)
  • Meets opiate dependence criteria (as determined by the SCID)
  • In good general physical and psychiatric health (except for possible acute drug use related problems)

You may not qualify if:

  • Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
  • Current cardiovascular disease (as determined by an electrocardiogram)
  • Circumstances will not allow for completion of study (on probation or parole)
  • Ethical constraints of supervision do not allow confidentiality (on probation or parole)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Interventions

ModafinilCitalopram

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropylaminesAminesNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Difficulty recruiting and lower than desired sample size.

Results Point of Contact

Title
Joy M Schmitz, PhD
Organization
The University of Texas Health Science Center at Houston
Joy.M.Schmitz@uth.tmc.edu
(713) 486-2867

Study Officials

  • Joy M Schmitz, PhD

    University of Texas

    PRINCIPAL INVESTIGATOR

  • F. Gerard Moeller, M.D.

    University of Texas Medical School at Houston

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
PRINCIPAL INVESTIGATOR
PI Title
Professor - Psy, Behavioral Science

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

July 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 16, 2018

Results First Posted

November 16, 2018

Record last verified: 2018-10

Locations

US(1)