Alcohol Use Disorders.NCT01362309
D-Cycloserine to Enhance Extinction to Alcohol Cues
A study testing d-cycloserine. in people with Alcohol Use Disorders., run by University of Georgia at 1 site in United States.
Trial summary
There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form of dysregulated learning and are influenced by classical conditioning. This is based on numerous studies indicating that conditioned contextual cues influence craving for alcohol consumption. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorders.
- What is being tested?
- d-cycloserine.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2012
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of an alcohol use disorder.
- At least 14+/7+ drinks/week for males/females.
- Alcohol cue reactivity.
- 9th grade education or greater.
- 21-65 years old.
- Stable contact information.
- Treatment-seeking.
Who cannot join
- Participation in a previous study of d-cycloserine.
- Mandated to treatment.
- Significant withdrawal symptoms (i.e., Clinical Institute Withdrawal Scale - Revised score of 15+, history of previous withdrawal-related hospitalizations, or withdrawal-related hallucinations).
- Current DSM IV Axis I conditions other than alcohol and nicotine dependence.
- Living with a previous study participant.
- No medical contraindications for d-cycloserine (i.e., currently taking ethionamide, isoniazid, SSRIs, history of epilepsy, history of hypersensitivity to DCS, or additional medical conditions deemed a risk at the physical exam by a study physician).
- Cardiovascular disease or uncontrolled hypertension (such conditions may contribute to abnormal psychophysiological arousal data), as determined by the study physician.
- Pregnant or seeking to conceive (females only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Experimental and Clinical Psychopharmacology Laboratory, Dept. of Psychology, University of Georgia
Athens, Georgia, 30605
About this study
There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form of dysregulated learning and are influenced by classical conditioning. This is based on numerous studies indicating that conditioned contextual cues influence craving for alcohol consumption. As a result, there has been considerable interest in extinction-based treatments for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues and motivation to drink), referred to as cue exposure treatment To date, extinction-based treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is considerable interest in improving this form of treatment. One novel strategy is the use of pharmacological adjuncts to enhance extinction. Medications that maximize extinction may minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes. This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues. Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will enhance extinction to alcohol cues under controlled laboratory conditions in treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will generate greater extinction compared to placebo during the subsequent extinction session as measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that DCS will generate greater extinction compared to placebo at follow-up assessments. This study is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under controlled laboratory conditions. It is a preliminary study using a subclinical number of extinction sessions and medication administrations to establish whether or not DCS improves extinction in the laboratory. If proof-of-concept is supported, it will suggest that a clinical trial is warranted. A clinical sample and clinical context are used to maximize the potential generalizability from this exploratory study.
- Conditions
- Alcohol Use Disorders.
- Being tested
- d-cycloserine.
- Keywords
- Alcohol, Cues, Extinction, D-Cycloserine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-cycloserine.Drug
Also called Seromycin.
50 mg administered on two occasions.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Inert filler in matched pill. Receives: Drug: d-cycloserine. |
| d-cycloserine 50 mg | Active comparator | 50 mg d-cycloserine. Receives: Drug: d-cycloserine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Craving for alcohol.
Subjective desire for alcohol is assessed intermittently during extended exposure to alcohol cues with response prevention within laboratory sessions and over the preceding week at 6 study visits.
Measured: Laboratory sessions (two, one-week apart): change in craving over 11 occasions, 5 minutes apart. Between sessions: change in craving across 7 occasions (Study Day: 1, 4, 7, 12, 19, 33, 40).
Secondary outcomes (1)
Change in Tolerability
Side effects resulting from d-cycloserine in individuals with alcohol use disorders.
Measured: Prevalence and change in side effects measured on 4 occasions (Study Day: 1, 4, 7, 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorders.Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, Brown University
- Responsible party
- Sponsor
- Investigators
- James MacKillop, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362309
- Sponsor's protocol ID
- R21AA017696
- Other IDs
- R21AA017696
- Status last verified
- May 2011
- First submitted
- 24 May 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Cycloserine to Enhance Extinction to Alcohol Cues
- ClinicalTrials.gov ID
- NCT01362309
- Acronym / sponsor ID
- R21AA017696
- Conditions
- Alcohol Use Disorders.
- Keywords
- Alcohol, Cues, Extinction, D-Cycloserine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, Brown University
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 May 2011 (estimated)
- 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.
There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form of dysregulated learning and are influenced by classical conditioning. This is based on numerous studies indicating that conditioned contextual cues influence craving for alcohol consumption. As a result, there has been considerable interest in extinction-based treatments for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues and motivation to drink), referred to as cue exposure treatment To date, extinction-based treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is considerable interest in improving this form of treatment. One novel strategy is the use of pharmacological adjuncts to enhance extinction. Medications that maximize extinction may minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes. This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues. Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will enhance extinction to alcohol cues under controlled laboratory conditions in treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will generate greater extinction compared to placebo during the subsequent extinction session as measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that DCS will generate greater extinction compared to placebo at follow-up assessments. This study is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under controlled laboratory conditions. It is a preliminary study using a subclinical number of extinction sessions and medication administrations to establish whether or not DCS improves extinction in the laboratory. If proof-of-concept is supported, it will suggest that a clinical trial is warranted. A clinical sample and clinical context are used to maximize the potential generalizability from this exploratory study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: d-cycloserine.Inert filler in matched pill. |
| d-cycloserine 50 mg | Active comparator | Drug: d-cycloserine.50 mg d-cycloserine. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of an alcohol use disorder.
- At least 14+/7+ drinks/week for males/females.
- Alcohol cue reactivity.
- 9th grade education or greater.
- 21-65 years old.
Key exclusion criteria (8 listed)
- Participation in a previous study of d-cycloserine.
- Mandated to treatment.
- Significant withdrawal symptoms (i.e., Clinical Institute Withdrawal Scale - Revised score of 15+, history of previous withdrawal-related hospitalizations, or withdrawal-related hallucinations).
- Current DSM IV Axis I conditions other than alcohol and nicotine dependence.
- Living with a previous study participant.
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 |
|---|---|---|
| d-cycloserine.Also: Seromycin.50 mg administered on two occasions. | Drug | Placebo, d-cycloserine 50 mg |
Primary outcome
Change in Craving for alcohol.
Time frame: Laboratory sessions (two, one-week apart): change in craving over 11 occasions, 5 minutes apart. Between sessions: change in craving across 7 occasions (Study Day: 1, 4, 7, 12, 19, 33, 40).
Subjective desire for alcohol is assessed intermittently during extended exposure to alcohol cues with response prevention within laboratory sessions and over the preceding week at 6 study visits.
1 secondary outcome
Change in Tolerability
Time frame: Prevalence and change in side effects measured on 4 occasions (Study Day: 1, 4, 7, 12)
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 19 Feb 2014.
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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.
James MacKillop, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing d-cycloserine. in people with Alcohol Use Disorders., run by University of Georgia 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 7 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 19 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
Change in Craving for alcohol. (time frame: Laboratory sessions (two, one-week apart): change in craving over 11 occasions, 5 minutes apart. Between sessions: change in craving across 7 occasions (Study Day: 1, 4, 7, 12, 19, 33, 40).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2014.