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Trial record 78 of 121 for:    CYCLOSERINE OR SEROMYCIN

Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

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ClinicalTrials.gov Identifier: NCT01067846
Recruitment Status : Completed
First Posted : February 12, 2010
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE February 10, 2010
First Posted Date  ICMJE February 12, 2010
Results First Submitted Date June 11, 2013
Results First Posted Date November 26, 2013
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • Drug Abstinence During Treatment and at Follow up Visits [ Time Frame: Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit ]
    Percentage of the overall number of drug abstinences of participants measured by urine drug testing
  • Treatment Retention - Number of Visits During Treatment [ Time Frame: Treatment sessions included 3 visits per week for 4 weeks ]
    Number of treatment visits attended prior to discontinuation of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2010)
Evaluation of the clinical efficacy (treatment retention and drug abstinence) and safety of D-cycloserine during therapeutic cocaine treatment [ Time Frame: D0 to D60 ]
Change History Complete list of historical versions of study NCT01067846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Enhancement and Relapse Prevention in Cocaine Addiction
Official Title  ICMJE The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy
Brief Summary

For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time.

One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time.

In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.

Detailed Description

Primary Hypothesis:

Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues.

Specific Aims:

  1. Determine if the short-term oral administration of DCS relative to placebo prior to CBT sessions facilitates cocaine abstinence and functional recovery, and reduces cocaine craving in treatment-seeking cocaine addicts.
  2. Determine if DCS administration relative to placebo facilitates CBT-related decreases in the behavioral and neural response to conditioned cocaine cues.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cocaine Addiction
Intervention  ICMJE
  • Drug: Seromycin (D-cycloserine, DCS)
    250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
    Other Name: D-cycloserine, DCS
  • Drug: Placebo
    Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
  • Behavioral: Computerized Cognitive Behavioral Therapy
    All participants received Computerized Cognitive Behavioral Therapy sessions 3 times per week for 4 weeks as a drug relapse intervention.
Study Arms
  • Experimental: DCS and Cognitive Behavioral Therapy
    Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
    Interventions:
    • Drug: Seromycin (D-cycloserine, DCS)
    • Behavioral: Computerized Cognitive Behavioral Therapy
  • Placebo Comparator: Placebo and Cognitive Behavioral Therapy
    Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
    Interventions:
    • Drug: Placebo
    • Behavioral: Computerized Cognitive Behavioral Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
85
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2010)
45
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible subjects must be cocaine-dependent persons between 18 and 65 years

Exclusion Criteria:

  • Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use
  • Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications
  • Positive history of loss of consciousness of greater than 10 min
  • Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable
  • History of hospitalization within the previous six months for a medical illness
  • Deafness, blindness or other significant sensory impairment.
  • Contraindications for D-cycloserine and magnetic resonance imaging.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01067846
Other Study ID Numbers  ICMJE 111989
R21DA025243 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Clinton Kilts, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP