Cocaine Use DisorderNCT03538548
Treatment Outcome in CBT for Cocaine Use
A study testing CBT-RP in people with Cocaine Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Cognitive-behavioral treatments for cocaine abuse could be improved by an increased understanding of factors that predict treatment outcomes. The objective of this protocol is to conduct a study examining the impact of client characteristics on the effects of cognitive-behavioral therapy for cocaine abuse. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- CBT-RP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2014to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals age 18-60.
- Currently report using cocaine via the intranasal or smoked route.
- Be able to give informed consent and comply with study procedures.
Who cannot join
- Individuals who meet current (i.e., within the past year) DSM-5 severe Substance Use Disorder (SUD) criteria (defined as the presence of 6 or more symptoms) for drugs other than cocaine, nicotine and caffeine.
- Individuals who meet current (i.e., within the past year) DSM-5 moderate to severe Major Depressive Disorder criteria (defined as a score of 17 or higher on the Hamilton Depression Rating Scale).
- Individuals who meet current DSM-5 criteria for any bipolar or psychotic disorder (other than transient psychosis due to drug use), or for all other psychiatric disorders not addressed by other exclusion criteria (e.g., anxiety disorders other than specific phobias, eating disorders, or ADHD) that require medical and/or psychological intervention.
- Individuals with a neurodevelopmental disorder (e.g., Intellectual Development Disorder, Autism Spectrum Disorder) except ADHD.
- Individuals with uncorrected visual or auditory deficits, or who cannot adequately read or understand the self-report assessment forms, or are so severely disabled they cannot comply with the requirements of the study.
- Individuals with current suicidal risk.
- Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program.
- Individuals who are currently receiving any professional treatment (e.g., therapy, medication) for substance abuse problems outside of the current research protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Predictors of Treatment Outcome in Cognitive-Behavioral Therapy for Cocaine Use
Cognitive-behavioral treatments for cocaine abuse could be improved by an increased understanding of factors that predict treatment outcomes. The objective of this protocol is to conduct a study examining the impact of client characteristics on the effects of cognitive-behavioral therapy for cocaine abuse.
Read the detailed description
Study investigators will recruit treatment-seeking cocaine users (n = 100) from a separate protocol (#6912) who will receive a standard 12-week course of cognitive behavioral therapy for relapse prevention. Using a variety of self-report questionnaires and computer-based tasks, three major domains will be assessed and evaluated as predictors of treatment outcome: (1) impulsivity, (2) motivation to change, and (3) learning style. Measures of these factors will have been obtained in the #6912 protocol. A better understanding of the impact of impulsivity, motivation to change, and learning style on treatment outcome will provide critical information to guide the refinement of CBT for cocaine abuse. For example, the results of this study may help guide the development and introduction of more targeted cognitive remedial strategies or behavioral training components into the framework of evidenced-based practices. These additions may help ameliorate the deleterious effects of specific participant characteristics on the acquisition and implementation of coping skills, which can further improve the efficacy of CBT.
- Conditions
- Cocaine Use Disorder
- Being tested
- CBT-RP
- Keywords
- Cocaine Abuse, Cocaine Use Disorder, Substance-Related Disorders
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-RPBehavioural
CBT-RP is a time-limited, manual guided intervention that aims to develop behavioral and cognitive skills needed to initiate abstinence and prevent relapse. The treatment will help individuals analyze the decision making process to minimize the influence of more immediate reinforcement, develop cognitive strategies to promote the attainment of longer-term goals, practice behavioral strategies to reduce the influence of socially mediated threats to abstinence, and outline explicit plans for managing situations that threaten their goal of abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants receive a standard 12-week course of Cognitive Behavioral Therapy for Relapse Prevention (CBT-RP; Carroll, 1998). The treatment protocol will be implemented over 12 weeks, with two 1-hour sessions per week for the first two weeks and one 1-hour session per week thereafter (i.e., a total of 14 sessions). Receives: Behavioral: CBT-RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement
Number of sessions attended
Measured: 12 Weeks
Treatment Completion
Dropout status (completion vs. non-completion)
Measured: 12 Weeks
Secondary outcomes (1)
Cocaine Use
Number of weeks of self-reported abstinence (verified by negative urinary drug screen)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start30 Sep 2014
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard Foltin, New York State Psychiatric Institute
- Investigators
- Richard Foltin, Ph.D., Principal investigator, Columbia University/New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538548
- Sponsor's protocol ID
- #7022
- Other IDs
- 1R01DA035846-01A1
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroll, K. M. (1998). A cognitive behavioral approach: treating cocaine addiction. Rockville, MD: National Institute on Drug Abuse.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Treatment Outcome in Cognitive-Behavioral Therapy for Cocaine Use
- ClinicalTrials.gov ID
- NCT03538548
- Acronym / sponsor ID
- #7022
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine Abuse, Cocaine Use Disorder, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive-behavioral treatments for cocaine abuse could be improved by an increased understanding of factors that predict treatment outcomes. The objective of this protocol is to conduct a study examining the impact of client characteristics on the effects of cognitive-behavioral therapy for cocaine abuse.
Detailed description
Study investigators will recruit treatment-seeking cocaine users (n = 100) from a separate protocol (#6912) who will receive a standard 12-week course of cognitive behavioral therapy for relapse prevention. Using a variety of self-report questionnaires and computer-based tasks, three major domains will be assessed and evaluated as predictors of treatment outcome: (1) impulsivity, (2) motivation to change, and (3) learning style. Measures of these factors will have been obtained in the #6912 protocol. A better understanding of the impact of impulsivity, motivation to change, and learning style on treatment outcome will provide critical information to guide the refinement of CBT for cocaine abuse. For example, the results of this study may help guide the development and introduction of more targeted cognitive remedial strategies or behavioral training components into the framework of evidenced-based practices. These additions may help ameliorate the deleterious effects of specific participant characteristics on the acquisition and implementation of coping skills, which can further improve the efficacy of CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: CBT-RPParticipants receive a standard 12-week course of Cognitive Behavioral Therapy for Relapse Prevention (CBT-RP; Carroll, 1998). The treatment protocol will be implemented over 12 weeks, with two 1-hour sessions per week for the first two weeks and one 1-hour session per week thereafter (i.e., a total of 14 sessions). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals age 18-60.
- Currently report using cocaine via the intranasal or smoked route.
- Be able to give informed consent and comply with study procedures.
Key exclusion criteria (8 listed)
- Individuals who meet current (i.e., within the past year) DSM-5 severe Substance Use Disorder (SUD) criteria (defined as the presence of 6 or more symptoms) for drugs other than cocaine, nicotine and caffeine.
- Individuals who meet current (i.e., within the past year) DSM-5 moderate to severe Major Depressive Disorder criteria (defined as a score of 17 or higher on the Hamilton Depression Rating Scale).
- Individuals who meet current DSM-5 criteria for any bipolar or psychotic disorder (other than transient psychosis due to drug use), or for all other psychiatric disorders not addressed by other exclusion criteria (e.g., anxiety disorders other than specific phobias, eating disorders, or ADHD) that require medical and/or psychological intervention.
- Individuals with a neurodevelopmental disorder (e.g., Intellectual Development Disorder, Autism Spectrum Disorder) except ADHD.
- Individuals with uncorrected visual or auditory deficits, or who cannot adequately read or understand the self-report assessment forms, or are so severely disabled they cannot comply with the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-RPCBT-RP is a time-limited, manual guided intervention that aims to develop behavioral and cognitive skills needed to initiate abstinence and prevent relapse. The treatment will help individuals analyze the decision making process to minimize the influence of more immediate reinforcement, develop cognitive strategies to promote the attainment of longer-term goals, practice behavioral strategies to reduce the influence of socially mediated threats to abstinence, and outline explicit plans for managing situations that threaten their goal of abstinence. | Behavioural | Treatment |
Primary outcome
Treatment Engagement
Time frame: 12 Weeks
Number of sessions attended
Treatment Completion
Time frame: 12 Weeks
Dropout status (completion vs. non-completion)
1 secondary outcome
Cocaine Use
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- BackgroundCarroll, K. M. (1998). A cognitive behavioral approach: treating cocaine addiction. Rockville, MD: National Institute on Drug Abuse.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Foltin, Ph.D. principal investigator
Columbia University/New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-RP in people with Cocaine Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Engagement (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.