D-Cycloserine Facilitation of Cocaine - Cue Extinction

NCT00759473 | Completed Phase 2 Results DMC

• 2 other identifiers: HRs#17972, 19784R01DA023188
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may lead to the development of new treatment options for cocaine dependence.

Conditions

Cocaine Use Disorders

Keywords

substance-related disorders

Outcome Measures

Primary Outcomes (1)

• Subjective Craving of Cocaine

  Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).

  two weeks

Study Arms (5)

Placebo/Placebo/Placebo/Placebo

PLACEBO COMPARATOR

Participants were assigned to receive placebo for each of 3 cue exposure sessions and at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.

Drug: Placebo

DCS/DCS/DCS/Placebo

EXPERIMENTAL

Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.

Drug: D-Cycloserine (DCS)

DCS/Placebo/DCS/Placebo

OTHER

Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the first and third cue exposure sessions and a placebo at the second cue exposure and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.

Drug: D-Cycloserine (DCS)

DCS/DCS/Placebo

EXPERIMENTAL

Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 2 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure sessions were accompanied by instructions on coping with craving.

Drug: D-Cycloserine (DCS)

Placebo/Placebo/Placebo

ACTIVE COMPARATOR

Participants were assigned to placebo for each of 2 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure sessions were accompanied by instructions on coping with craving.

Drug: Placebo

Interventions

D-Cycloserine (DCS) DRUG

50 mg d-cycloserine or placebo taken orally

Also known as: seromycin

DCS/DCS/DCS/Placebo; DCS/DCS/Placebo; DCS/Placebo/DCS/Placebo

Placebo DRUG

Placebo/Placebo/Placebo; Placebo/Placebo/Placebo/Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
• Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance with the exceptions of nicotine and alcohol. Because of the high comorbidity of cocaine with alcohol and nicotine dependence, excluding nicotine and alcohol dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue exposure/extinction session will be controlled. Although individuals who meet criteria for alcohol dependence will be accepted for study participation, anyone who has a measurable blood alcohol level on the day of the sessions will be excluded as acute alcohol intake can increase serum levels of DCS and lower the seizure threshold.
• Use of one of the following methods of birth control by female subjects: birth control pills, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
• Subjects must live within a 50-mile radius of the research facility and have reliable transportation.
• Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) prior to the first session and through the final session.
• Subjects must consent to random assignment to the DCS vs. placebo conditions.
• For fMRI participants, subjects must be right-handed.

You may not qualify if:

• Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
• Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including insulin-dependent diabetes, as these conditions may affect heart rate or skin conductance measurement.
• Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
• Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) prior to and between the cue procedures.
• Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, alcohol or cocaine as appropriate) within the past 60 days.
• Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
• Known or suspected hypersensitivity to DCS.
• Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
• Subjects with a history of epilepsy or seizure disorder.
• Subjects with significant liver impairment, as DCS may increase serum transaminases.
• For fMRI participants, the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
• For fMRI participants, clinically significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

Location

Related Publications (2)

• Prisciandaro JJ, Joseph JE, Myrick H, McRae-Clark AL, Henderson S, Pfeifer J, Brady KT. The relationship between years of cocaine use and brain activation to cocaine and response inhibition cues. Addiction. 2014 Dec;109(12):2062-70. doi: 10.1111/add.12666. Epub 2014 Jul 21.

  PMID: 24938849 DERIVED

• Prisciandaro JJ, Myrick H, Henderson S, McRae-Clark AL, Santa Ana EJ, Saladin ME, Brady KT. Impact of DCS-facilitated cue exposure therapy on brain activation to cocaine cues in cocaine dependence. Drug Alcohol Depend. 2013 Sep 1;132(1-2):195-201. doi: 10.1016/j.drugalcdep.2013.02.009. Epub 2013 Mar 14.

  PMID: 23497788 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. McRae-Clark
• Organization: MUSC

mcraeal@musc.edu

843-792-5216

Study Officials

• Kathleen T Brady, M.D., Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 13, 2016
• Results First Posted: July 10, 2013

Record last verified: 2016-03

Locations

US (2)