Alcohol Use Disorder (AUD)Phase 2PERRASNCT05181891
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
A Phase 2 study testing Contingency Management in people with Alcohol Use Disorder (AUD) and Nicotine Use Disorder, run by Washington State University at 1 site in United States.
Trial summary
Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Nicotine Use Disorder
- What is being tested?
- Contingency Management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days
- Seeking AUD treatment
- Seeking smoking cessation treatment
- Aged 18+ years
- DSM-5 diagnosis of AUD
- Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)
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- Ability to read and speak English
- Ability to provide written informed consent
- Breath alcohol of 0.00 during informed consent
- Provision of at least 1 EtG-positive urine test at any time during the induction period and at least one COT-positive urine test at any time during the induction period; and
- Attended at least 4 of 6 possible visits during the induction period.
Who cannot join
- Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
- Currently receiving any pharmacotherapy for alcohol
- Currently receiving any pharmacotherapy for smoking
- No suicide attempt in the last 20 years and
- Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington State University
Spokane, Washington, 99202
Research Coordinator, 509-638-2376, wsu.appl@wsu.edu
About this study
Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.
Read the detailed description
This randomized, placebo-controlled trial to determine the effectiveness of contingency management for reducing alcohol use and cigarette smoking among adults who want to quit or reduce their co-addiction. Contingency management is a powerful and cost-effective technique that has been used successfully for decades to promote abstinence from benzodiazepines, cocaine, tobacco, etc. Contingency management, and a non-contingent control condition will be used combined with varenicline (VC) and manualized counseling in the form of module videos.
- Conditions
- Alcohol Use Disorder (AUD), Nicotine Use Disorder
- Being tested
- Contingency Management, Non-contingent control
- Keywords
- Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder
- Medical subject headings
- Alcoholism, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
Incentives for submitting negative-alcohol urine samples
Non-contingent controlBehavioural
Incentives for submitting urine samples
| Study group | Role | What they receive |
|---|---|---|
| (CM+TAU) Contingency Management + Treatment as Usual | Experimental | Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. Participants in CM+TAU will receive reinforcement for submitting urine samples that test negative for recent alcohol use. Receives: Behavioral: Contingency Management |
| (NC+TAU) No Contingency + Treatment as Usual | Active comparator | Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. NC+TAU will receive reinforcement for submitting any urine sample, regardless of test results. Receives: Behavioral: Non-contingent control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biochemically Verified Alcohol Use
Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by alcohol EtG values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Measured: 12-week treatment period and 7-month follow-up period
Change in Biochemically Verified Tobacco Use
Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by tobacco CO and COT values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Measured: 12-week treatment period and 7-month follow-up period
Secondary outcomes (2)
Change in Self Reported Alcohol Use
Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Measured: 12-week treatment period and 7-month follow-up period
Change in Self Reported Tobacco Use
Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Measured: 12-week treatment period and 7-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start11 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II randomized trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sterling McPherson, Washington State University
- Investigators
- Sterling M McPherson, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181891
- Sponsor's protocol ID
- 18668-001
- Acronym
- PERRAS
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
- ClinicalTrials.gov ID
- NCT05181891
- Acronym / sponsor ID
- PERRAS / 18668-001
- Conditions
- Alcohol Use Disorder (AUD), Nicotine Use Disorder
- Keywords
- Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Jan 2022 (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.
Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.
Detailed description
This randomized, placebo-controlled trial to determine the effectiveness of contingency management for reducing alcohol use and cigarette smoking among adults who want to quit or reduce their co-addiction. Contingency management is a powerful and cost-effective technique that has been used successfully for decades to promote abstinence from benzodiazepines, cocaine, tobacco, etc. Contingency management, and a non-contingent control condition will be used combined with varenicline (VC) and manualized counseling in the form of module videos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Phase II randomized trial
| Arm | Type | Receives |
|---|---|---|
| (CM+TAU) Contingency Management + Treatment as Usual | Experimental | Behavioral: Contingency ManagementVarenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. Participants in CM+TAU will receive reinforcement for submitting urine samples that test negative for recent alcohol use. |
| (NC+TAU) No Contingency + Treatment as Usual | Active comparator | Behavioral: Non-contingent controlVarenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. NC+TAU will receive reinforcement for submitting any urine sample, regardless of test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days
- Seeking AUD treatment
- Seeking smoking cessation treatment
- Aged 18+ years
- DSM-5 diagnosis of AUD
Key exclusion criteria (5 listed)
- Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
- Currently receiving any pharmacotherapy for alcohol
- Currently receiving any pharmacotherapy for smoking
- No suicide attempt in the last 20 years and
- Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.
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 |
|---|---|---|
| Contingency ManagementIncentives for submitting negative-alcohol urine samples | Behavioural | (CM+TAU) Contingency Management + Treatment as Usual |
| Non-contingent controlIncentives for submitting urine samples | Behavioural | (NC+TAU) No Contingency + Treatment as Usual |
Primary outcome
Change in Biochemically Verified Alcohol Use
Time frame: 12-week treatment period and 7-month follow-up period
Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by alcohol EtG values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
Change in Biochemically Verified Tobacco Use
Time frame: 12-week treatment period and 7-month follow-up period
Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by tobacco CO and COT values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).
2 secondary outcomes
Change in Self Reported Alcohol Use
Time frame: 12-week treatment period and 7-month follow-up period
Change in Self Reported Tobacco Use
Time frame: 12-week treatment period and 7-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.
Sterling M McPherson, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contingency Management in people with Alcohol Use Disorder (AUD) and Nicotine Use Disorder, run by Washington State 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (509-638-2376, wsu.appl@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Biochemically Verified Alcohol Use (time frame: 12-week treatment period and 7-month follow-up period). 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?
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 6 Jul 2026.