NCT01526538

Brief Summary

This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 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

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

February 15, 2017

Status Verified

December 1, 2016

Enrollment Period

1.5 years

First QC Date

January 30, 2012

Results QC Date

September 10, 2015

Last Update Submit

December 22, 2016

Conditions

COCAINE-RELATED DISORDERS

Outcome Measures

Primary Outcomes (2)

  • Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)

    The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results

    1 month post-treatment

  • Medication Side-effects

    self-report of medication side effects (Units of Measure is the count of specific reported effects)

    1 month post-treatment.

Secondary Outcomes (1)

  • Learning Task by Itami and Uno

    At the baseline laboratory visit

Study Arms (2)

50 mg d-cycloserine

EXPERIMENTAL

active drug condition

Drug: d-cycloserine

Sugar pill

PLACEBO COMPARATOR

Inactive placebo

Drug: sugar pill

Interventions

d-cycloserineDRUG

50 mg d-cycloserine

50 mg d-cycloserine
sugar pillDRUG

placebo

Sugar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age (\> 60 due to age-related effects on cognitive functioning)
  • Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
  • Able to complete all study measures
  • Currently seeking treatment for cocaine dependence

You may not qualify if:

  • Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
  • Pregnant, breast feeding, or planning to become pregnant within 3 months
  • If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
  • History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
  • Diagnosis of current major psychiatric disorder besides substance dependence or abuse
  • Reported use of DCS in the past year
  • Illiteracy, as will be determined during in-person screening
  • Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
  • Positive urine result for opioids at screening interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 212124, United States

Location

Related Publications (1)

  • Johnson MW, Bruner NR, Johnson PS, Silverman K, Berry MS. Randomized controlled trial of d-cycloserine in cocaine dependence: Effects on contingency management and cue-induced cocaine craving in a naturalistic setting. Exp Clin Psychopharmacol. 2020 Apr;28(2):157-168. doi: 10.1037/pha0000306. Epub 2019 Aug 1.

    PMID: 31368770DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

CycloserineSugars

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Results Point of Contact

Title
Matthew Johnson Ph.D.
Organization
Johns Hopkins University
mwj@jhu.edu
4105500056

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
Assistant Professor

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 6, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 15, 2017

Results First Posted

February 15, 2017

Record last verified: 2016-12

Locations

US(1)