PainPhase 1NCT03311594
The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
A Phase 1 study testing Low Alcohol, Moderate Alcohol and Pain Induction in people with Pain and Alcohol Drinking, run by Syracuse University at 1 site in United States.
Trial summary
The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants the existing research investment into their etiology and treatment. Moreover, evidence of significant co-occurrence between these conditions offers an opportunity to examine mechanisms in the alcohol-pain connection that may… Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Alcohol Drinking, Acute Pain
- What is being tested?
- Low Alcohol, Moderate Alcohol and Pain Induction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 379 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2019to 30 Jun 2022
- Phase
- Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be 21-64 years of age
- be classified as a moderate or heavy drinker based on the Quantity-Frequency-Variability Questionnaire, which will assure that participants currently (last 3 months) consume alcohol in amounts similar to what will be administered or available in the proposed experiments
Who cannot join
- current acute or chronic pain
- chili pepper allergies (contraindicated for capsaicin)
- current use of prescription pain medications
- any possibility of being pregnant (verified at session via a pregnancy test)
- self-reported history of or treatment for psychiatric or alcohol/other drug problems
- participants who are under the age of 21 or who do not have a government issued ID; and
- medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease).
Trial locations and contacts
1 site in 1 country.
About this study
The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants the existing research investment into their etiology and treatment. Moreover, evidence of significant co-occurrence between these conditions offers an opportunity to examine mechanisms in the alcohol-pain connection that may inform the development of novel treatments. Consistent with NIH PA-15-026 (Mechanistic Studies of Pain and Alcohol Dependence), the goal of the proposed study is to examine several complex and potentially bidirectional relations between pain and alcohol in one overarching model, which has never been attempted in a human experimental paradigm. The primary study aims are as follows: (1) to conduct the first test of both pharmacological and expectancy effects in acute alcohol analgesia among humans; (2) to conduct the first test of pain as a proximal antecedent of urge to drink and ad lib alcohol consumption, and to test whether acute analgesic effects predict pain-induced alcohol urge/consumption; (3) to test associations between study outcomes and candidate genetic polymorphisms that have been implicated in pain-alcohol processes; and (4) to conduct exploratory analyses of gender and pain relevant cognitive-affective factors as moderators of these outcomes. Participants will include 280 moderate-to-heavy drinkers recruited from the local community. Experimental methods will include alcohol administration (moderate dose vs. low dose vs. placebo vs. control) and pre/post assessment of static/dynamic pain responses, and capsaicin/heat pain induction (vs. no pain induction) followed by assessment of urge to drink and ad lib alcohol consumption. By employing a novel experimental paradigm, the study results will provide internally valid data with clear and direct implications for translating these findings to clinical applications. It is our expectation that this work will catalyze future research and inform clinical practice by establishing an experimental platform that allows for the demonstration of causal effects, the evaluation of treatment components prior to conducting costly clinical trials, and the identification of important theory-based biopsychosocial mechanisms that can inform the development of novel integrated treatments for individuals with co-occurring pain and alcohol use disorders.
- Conditions
- Pain, Alcohol Drinking, Acute Pain, Drinking Behavior
- Being tested
- Low Alcohol, Moderate Alcohol, Placebo Alcohol, Pain Induction, No Pain Induction
- Keywords
- Alcohol, Pain
- Medical subject headings
- Pain, Alcohol Drinking, Acute Pain, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low AlcoholDrug
Low Alcohol Consumption
Moderate AlcoholDrug
Moderate Alcohol Consumption
Placebo AlcoholDrug
Placebo Alcohol Consumption
Pain InductionOther
10% capsaicin solution placed on forearm and heat induction
No Pain InductionOther
Water placed on forearm
| Study group | Role | What they receive |
|---|---|---|
| Low Alcohol Consumption and No Pain Induction | Experimental | Condition 1: Low alcohol consumption Condition 2: No pain group Receives: Drug: Low Alcohol; Other: No Pain Induction |
| Low Alcohol Consumption and Pain Induction | Experimental | Condition 1: Low alcohol consumption Condition 2: Pain group Receives: Drug: Low Alcohol; Other: Pain Induction |
| Moderate Alcohol Consumption and No Pain Induction | Experimental | Condition 1: Moderate alcohol consumption Condition 2: No pain group Receives: Drug: Moderate Alcohol; Other: No Pain Induction |
| Moderate Alcohol Consumption and Pain Induction | Experimental | Condition 1: Moderate alcohol consumption Condition 2: Pain group Receives: Drug: Moderate Alcohol; Other: Pain Induction |
| Placebo Alcohol Consumption and No Pain Induction | Placebo comparator | Condition 1: Placebo alcohol consumption Condition 2: No pain group Receives: Drug: Placebo Alcohol; Other: No Pain Induction |
| Placebo Alcohol Consumption and Pain Induction | Experimental | Condition 1: Placebo alcohol consumption Condition 2: Pain group Receives: Drug: Placebo Alcohol; Other: Pain Induction |
| Control and No Pain Induction | Placebo comparator | Condition 1: No alcohol consumption Condition 2: No pain group Receives: Other: No Pain Induction |
| Control and Pain Induction | Experimental | Condition 1: No alcohol consumption Condition 2: Pain group Receives: Other: Pain Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Urge/Consumption
Amount of alcohol consumed and self-reported urge to drink
Measured: 15 minutes
Pain Response
Pain Quantitative Sensory Testing before and after beverage consumption
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start12 May 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 PainStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Joseph W. Ditre, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311594
- Sponsor's protocol ID
- 5R01AA024844-02
- Other IDs
- 5R01AA024844
- Status last verified
- Aug 2022
- First submitted
- 11 Oct 2017
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ditre JW, LaRowe LR, Powers JM, White KM, Paladino MB, Zvolensky MJ, Glatt S, Maisto SA. Pain as a causal motivator of alcohol consumption: Associations with gender and race. J Psychopathol Clin Sci. 2023 Jan;132(1):101-109. doi: 10.1037/abn0000792. Epub 2022 Dec 8.
PubMed 36480413
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates
- ClinicalTrials.gov ID
- NCT03311594
- Acronym / sponsor ID
- 5R01AA024844-02
- Conditions
- Pain, Alcohol Drinking, Acute Pain, Drinking Behavior
- Keywords
- Alcohol, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 12 May 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Oct 2017 (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.
The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants the existing research investment into their etiology and treatment. Moreover, evidence of significant co-occurrence between these conditions offers an opportunity to examine mechanisms in the alcohol-pain connection that may inform the development of novel treatments. Consistent with NIH PA-15-026 (Mechanistic Studies of Pain and Alcohol Dependence), the goal of the proposed study is to examine several complex and potentially bidirectional relations between pain and alcohol in one overarching model, which has never been attempted in a human experimental paradigm. The primary study aims are as follows: (1) to conduct the first test of both pharmacological and expectancy effects in acute alcohol analgesia among humans; (2) to conduct the first test of pain as a proximal antecedent of urge to drink and ad lib alcohol consumption, and to test whether acute analgesic effects predict pain-induced alcohol urge/consumption; (3) to test associations between study outcomes and candidate genetic polymorphisms that have been implicated in pain-alcohol processes; and (4) to conduct exploratory analyses of gender and pain relevant cognitive-affective factors as moderators of these outcomes. Participants will include 280 moderate-to-heavy drinkers recruited from the local community. Experimental methods will include alcohol administration (moderate dose vs. low dose vs. placebo vs. control) and pre/post assessment of static/dynamic pain responses, and capsaicin/heat pain induction (vs. no pain induction) followed by assessment of urge to drink and ad lib alcohol consumption. By employing a novel experimental paradigm, the study results will provide internally valid data with clear and direct implications for translating these findings to clinical applications. It is our expectation that this work will catalyze future research and inform clinical practice by establishing an experimental platform that allows for the demonstration of causal effects, the evaluation of treatment components prior to conducting costly clinical trials, and the identification of important theory-based biopsychosocial mechanisms that can inform the development of novel integrated treatments for individuals with co-occurring pain and alcohol use disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Low Alcohol Consumption and No Pain Induction | Experimental | Drug: Low Alcohol, Other: No Pain InductionCondition 1: Low alcohol consumption Condition 2: No pain group |
| Low Alcohol Consumption and Pain Induction | Experimental | Drug: Low Alcohol, Other: Pain InductionCondition 1: Low alcohol consumption Condition 2: Pain group |
| Moderate Alcohol Consumption and No Pain Induction | Experimental | Drug: Moderate Alcohol, Other: No Pain InductionCondition 1: Moderate alcohol consumption Condition 2: No pain group |
| Moderate Alcohol Consumption and Pain Induction | Experimental | Drug: Moderate Alcohol, Other: Pain InductionCondition 1: Moderate alcohol consumption Condition 2: Pain group |
| Placebo Alcohol Consumption and No Pain Induction | Placebo comparator | Drug: Placebo Alcohol, Other: No Pain InductionCondition 1: Placebo alcohol consumption Condition 2: No pain group |
| Placebo Alcohol Consumption and Pain Induction | Experimental | Drug: Placebo Alcohol, Other: Pain InductionCondition 1: Placebo alcohol consumption Condition 2: Pain group |
| Control and No Pain Induction | Placebo comparator | Other: No Pain InductionCondition 1: No alcohol consumption Condition 2: No pain group |
| Control and Pain Induction | Experimental | Other: Pain InductionCondition 1: No alcohol consumption Condition 2: Pain group |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- be 21-64 years of age
- be classified as a moderate or heavy drinker based on the Quantity-Frequency-Variability Questionnaire, which will assure that participants currently (last 3 months) consume alcohol in amounts similar to what will be administered or available in the proposed experiments
Key exclusion criteria (7 listed)
- current acute or chronic pain
- chili pepper allergies (contraindicated for capsaicin)
- current use of prescription pain medications
- any possibility of being pregnant (verified at session via a pregnancy test)
- self-reported history of or treatment for psychiatric or alcohol/other drug problems
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 |
|---|---|---|
| Low AlcoholLow Alcohol Consumption | Drug | Low Alcohol Consumption and No Pain Induction, Low Alcohol Consumption and Pain Induction |
| Moderate AlcoholModerate Alcohol Consumption | Drug | Moderate Alcohol Consumption and No Pain Induction, Moderate Alcohol Consumption and Pain Induction |
| Placebo AlcoholPlacebo Alcohol Consumption | Drug | Placebo Alcohol Consumption and No Pain Induction, Placebo Alcohol Consumption and Pain Induction |
| Pain Induction10% capsaicin solution placed on forearm and heat induction | Other | Control and Pain Induction, Low Alcohol Consumption and Pain Induction, Moderate Alcohol Consumption and Pain Induction, Placebo Alcohol Consumption and Pain Induction |
| No Pain InductionWater placed on forearm | Other | Control and No Pain Induction, Low Alcohol Consumption and No Pain Induction, Moderate Alcohol Consumption and No Pain Induction, Placebo Alcohol Consumption and No Pain Induction |
Primary outcome
Alcohol Urge/Consumption
Time frame: 15 minutes
Amount of alcohol consumed and self-reported urge to drink
Pain Response
Time frame: 40 minutes
Pain Quantitative Sensory Testing before and after beverage consumption
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 17 Aug 2022.
- Derived from this study: PubMed 36480413Ditre JW, LaRowe LR, Powers JM, White KM, Paladino MB, Zvolensky MJ, Glatt S, Maisto SA. Pain as a causal motivator of alcohol consumption: Associations with gender and race. J Psychopathol Clin Sci. 2023 Jan;132(1):101-109. doi: 10.1037/abn0000792. Epub 2022 Dec 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Alcohol, Moderate Alcohol and Pain Induction in people with Pain and Alcohol Drinking, run by Syracuse University 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 2 inclusion and 7 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 17 Aug 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alcohol Urge/Consumption (time frame: 15 minutes). 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 NCT03311594, 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 17 Aug 2022.