Sleep Disorders Trial, Recruiting NCT04725617 Sponsor: University of Arizona Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT04725617
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 75 years, of any gender
  • People who have a confirmed HIV diagnosis
  • People whose CD4+ T cell count (a measure of immune system health) is at least 200 cells/mm³
  • People who are either on a stable HIV medication regimen with no plans to change it, or not currently on HIV medication with no immediate plans to start
  • People who smoke at least 5 cigarettes per day
  • People who want to quit smoking within the next month
  • People who do not have a sleep disorder, with the exception of insomnia or mild-to-moderate sleep apnea (confirm with trial site if unsure about sleep apnea severity)
  • People who can communicate in English and provide written consent to take part
  • People for whom the study medication (varenicline tartrate) is considered safe to take
  • People who will be living in the local area for at least 10 months
  • People who are willing to attend 8 in-person study sessions and one follow-up appointment at 6 months

Who may not be able to join:

  • People who regularly use chewing tobacco, snuff, cigars, or e-cigarettes and are not willing to stop during the study
  • People who are currently enrolled in, or planning to join, another quit-smoking program or use other quit-smoking products during the study period
  • Women who are pregnant, breastfeeding, or likely to become pregnant during the trial and are not willing to use contraception
  • People whose alcohol use is considered unstable in a way that would affect their ability to reliably take part, as assessed by the study doctor
  • People whose drug use is considered unstable in a way that would affect their ability to reliably take part, as assessed by the study doctor
  • People whose mental health condition is considered unstable in a way that would affect their ability to reliably take part, as assessed by the study doctor
  • People who have attempted suicide in the last two years, or who are currently experiencing suicidal thoughts as measured by a specific clinical scale
  • People with moderate or severe depression that is unstable or untreated, as measured by a standard depression questionnaire
  • People who have had a serious or unstable medical condition in the past 6 months, such as cancer, seizures, advanced liver or kidney disease, uncontrolled diabetes, or a lung condition requiring oxygen
  • People who have had a seizure disorder within the past year
  • People who have had an unstable heart condition (such as chest pain, a heart attack, or a heart procedure) in the past 6 months, or whose heart test results suggest a health or safety concern
  • People who currently work night shifts or rotating shifts, or who take medication that could affect sleep
  • People who have a history of sleepwalking as an adult
  • People who take sleep medication that could interfere with the study results
  • People who, in the investigators' judgement, are unable to complete the study tasks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Elizabeth Connick, MD, University of Arizona

Phone: (520) 626-7873

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Arizona
Registry
ClinicalTrials.gov
Start date
16 November 2021
Est. completion
28 September 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in smoking cessation; Change in sleep duration

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov