Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01067846
First received: February 10, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Cocaine Addiction
Drug: Seromycin (D-cycloserine, DCS)
Drug: Placebo
Behavioral: Computerized Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of treatment visits attended prior to discontinuation of treatment


Enrollment: 85
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCS and Cognitive Behavioral Therapy
Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.
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
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.
Placebo Comparator: Placebo and Cognitive Behavioral Therapy
Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067846

Locations
United States, Arkansas
Psychiatric Research Institute (PRI) (Center for Addiction Research (CAR) and Brain Imaging Research Center (BIRC)) University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Clinton Kilts, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01067846     History of Changes
Other Study ID Numbers: 111989, R21DA025243
Study First Received: February 10, 2010
Results First Received: June 11, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
cocaine dependence
relapse prevention
computerized cognitive behavioral therapy (CBT)
D-cycloserine (DCS)

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Cocaine
Cycloserine
Nootropic Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014