Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

University of Arkansas

Status: Completed

Conditions: Cocaine Addiction

Treatments: Behavioral: Computerized Cognitive Behavioral Therapy; Drug: Seromycin (D-cycloserine, DCS); Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01067846

111989

R21DA025243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups, including a placebo group

DCS and Cognitive Behavioral Therapy

Experimental group

Description:

Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.

Treatment:

Drug: Seromycin (D-cycloserine, DCS)

Behavioral: Computerized Cognitive Behavioral Therapy

Placebo and Cognitive Behavioral Therapy

Placebo Comparator group

Description:

Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.

Treatment:

Drug: Placebo

Behavioral: Computerized Cognitive Behavioral Therapy